Example 5: Manufacturer report : Injury

Johnson & Johnson

CORDIS CASHEL

EI

reporter occupation: 000 OTHER
MAUDE link: https://XXXXXX

dates

Report Date: 2017-12-12
Event Date: 2015-12-29
Mfr Rec’d Date: 2017-11-16
FDA Rec’d Date: 2017-12-12
Date Added: 2017-12-12
Date Changed: 2017-12-17

device

  • product code: DTK
  • device name: Filter , Intravascular, Cardiovascular
  • brand: 466FXXXX
  • generic: FILTER , INTRAVASCULAR, CARDIOVASCULAR
  • operator: 0HP HEALTH PROFESSIONAL
  • model #:
  • catalog #: 466FXXXX
  • lot #: UNK
  • other ID #:
  • evaluated by manufacturer: *
  • available: N
  • expires:
  • PMA/510K #:

description

AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER . THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, BLOOD CLOTS, CLOTTING AND OCCLUSION OF THE INFERIOR VENA CAVA ( IVC ) FILTER . AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FROM (PPF) INDICATES THAT THE PATIENT HAD TWO FILTERS IMPLANTED TWENTY-ONE DAYS APART FROM EACH OTHER. THE FILTER , ALTHOUGH IT IS UNKNOWN WHICH, IS EMBEDDED IN THE WALL OF THE IVC . ACCORDING TO THE PPF, THE PATIENT HAD THE FIRST FILTER THAT WAS IMPLANTED REMOVED TWELVE DAYS POST IMPLANTATION. THE SECOND FILTER REMAINS IMPLANTED. THE PATIENT ALSO REPORTS TO BE SUFFERING FROM LEG PAIN, PAIN AT THE SITE OF THE IMPLANT, CRAMPING, NAUSEA, MENTAL ANGUISH AND DIZZINESS. SIX YEARS AND ELEVEN MONTHS POST THE FIRST IMPLANTATION, THE PATIENT PRESENTED TO THE HOSPITAL WITH A FILLING DEFECT AND BILATERAL DEEP VEIN THROMBOSIS. THE IVC AND THE ILIAC VEINS SHOWED A LACK OF BLOOD FLOW BELOW THE FILTER . ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD A HISTORY OF ACUTE DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LEG AND WAS ADMITTED TO THE HOSPITAL FOR WORSENING OF THE DVT WHILE ON ANTICOAGULATION. THE PATIENT HAS COMPARTMENT SYNDROME. THE PATIENT ALSO HAD RECENTLY, PRIOR TO THE FIRST FILTER IMPLANTATION, UNDERGONE SURGERY AND HAD FASCIOTOMY WOUNDS AND HEMATOMAS. ORIGINALLY, THE PATIENT TOLERATED THE INDEX PROCEDURE WELL AND THE FILTER WAS SUCCESSFULLY DEPLOYED BELOW THE RENAL VEINS. FOR THE SECOND FILTER IMPLANTATION PROCEDURE, THE PATIENT DEVELOPED A PULMONARY EMBOLUS (PE) WHILE ON ANTICOAGULATION AND HAD A BLEED SECONDARY TO ANTICOAGULATION IN THE LEFT LEG. THE SECONDFILTER WAS ALSO SUCCESSFULLY DEPLOYED, THE PATIENT TOLERATED THE INDEX PROCEDURE WELL AND LEFT RECOVERY IN STABLE CONDITION.

other elements

  •  7108084
  •  1016427-2017-00874
  •  Y
  •  Y
  •  Y
  •  2017-12-12
  •  2015-12-29
  •  N
  •  N
  •  2017-11-16
  •  Y
  •  I
  •  2017-12-12
  •  2017-12-17
  •  IN
  •  Injury
  •  M
  •  Manufacturer report
  •  000
  •  OTHER
  •  N
  •  No
  •  *
  •  No answer provided
  •  I
  •  Initial submission
  •  COMPANY REPRESENTATIVE
  •  COMPANY REPRESENTATIVE
  •  OTHER
  •  OTHER
  •  I
  •  Johnson & Johnson
  •  CORDIS CASHEL
  •  CAHIR ROAD
  •  CASHEL, CO. TIPPERARY
  •  EI
  •  AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF TWO OPTEASE INFERIOR VENA CAVA (IVCFILTERS. PER THE MEDICAL RECORDS, THE PATIENT HAD A HISTORY OF ACUTE DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LEG AND WAS ADMITTED TO THE HOSPITAL FOR WORSENING OF THE DVT WHILE ON ANTICOAGULATION. THE PATIENT HAD RECENTLY BEEN DIAGNOSED WITH COMPARTMENT SYNDROME. THE PATIENT ALSO HAD RECENTLY, PRIOR TO THE FIRST FILTER IMPLANTATION, UNDERGONE SURGERY AND HAD FASCIOTOMY WOUNDS AND HEMATOMAS. ORIGINALLY, THE PATIENT TOLERATED THE INDEX PROCEDURE WELL AND THE FILTER WAS SUCCESSFULLY DEPLOYED BELOW THE RENAL VEINS. FOR THE SECOND FILTER IMPLANTATION PROCEDURE, THE PATIENT DEVELOPED A PULMONARY EMBOLUS (PE) WHILE ON ANTICOAGULATION AND HAD A BLEED SECONDARY TO ANTICOAGULATION IN THE LEFT LEG. THE SECOND FILTER WAS ALSO SUCCESSFULLY DEPLOYED, THE PATIENT TOLERATED THE INDEX PROCEDURE WELL AND LEFT RECOVERY IN STABLE CONDITION. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, BLOOD CLOTS, CLOTTING AND OCCLUSION OF THE INFERIOR VENA CAVA (IVCFILTER. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FROM (PPF) INDICATES THAT THE PATIENT HAD TWO FILTERSIMPLANTED TWENTY-ONE DAYS APART FROM EACH OTHER. THE FILTER, ALTHOUGH IT IS UNKNOWN WHICH, IS EMBEDDED IN THE WALL OF THE IVC. ACCORDING TO THE PPF, THE PATIENT HAD THE FIRST FILTER THAT WAS IMPLANTED REMOVED TWELVE DAYS POST IMPLANTATION. THE SECOND FILTER REMAINS IMPLANTED. THE PATIENT ALSO REPORTS TO BE SUFFERING FROM LEG PAIN, PAIN AT THE SITE OF THE IMPLANT, CRAMPING, NAUSEA, MENTAL ANGUISH AND DIZZINESS. SIX YEARS AND ELEVEN MONTHS POST THE FIRST IMPLANTATION, THE PATIENT PRESENTED TO THE HOSPITAL WITH A FILLING DEFECT AND BILATERAL DEEP VEIN THROMBOSIS. THE IVC AND THE ILIAC VEINS SHOWED A LACK OF BLOOD FLOW BELOW THE FILTER. THE FIRST FILTER THAT WAS REMOVED IS UNAVAILABLE FOR ANALYSIS. THE SECOND FILTER REMAINS IMPLANTED; THUS, ALSO, UNAVAILABLE FOR ANALYSIS. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS AND THE STERILE LOT NUMBERS HAVE NOT BEEN PROVIDED; THEREFORE, NO DEVICE ANALYSIS NOR DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. THE OPTEASE VENA CAVA FILTER IS INDICATED FOR USE IN THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PERCUTANEOUS PLACEMENT IN THE VENA CAVA FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED, OR IS CONTRAINDICATED. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. BLOOD CLOTS AND OCCLUSIVE THROMBOSIS WITHIN THE FILTER DO NOT REPRESENT A DEVICE MALFUNCTION. THE PREDOMINANT CONCERN FOR EMBEDDING WITH IN THE WALL OF THE IVC IS THE DEVELOPMENT OF ENDOTHELIALIZATION. ENDOTHELIALIZATION IS THE HEALING OF THE INNER SURFACES OF VESSELS OR GRAFTS BY ENDOTHELIAL CELLS. THIS IS THE NORMAL PROCESS WHEREBY THE BODY HEALS AND RECOVERS FROM INVASIVE PROCEDURES. ENDOTHELIALIZATION HAS BEEN SHOWN TO OCCUR IN AS SHORT A PERIOD AS 12 DAYS. POOR PERIPHERAL CIRCULATION AND PAIN DO NOT REPRESENT DEVICE MALFUNCTIONS, THEY MAY BE RELATED TO THE UNDERLYING CLOTTING ISSUES EXPERIENCE PRIOR TO FILTER IMPLANTATION. ANXIETY, DIZZINESS AND NAUSEA DO NOT REPRESENT DEVICE MALFUNCTIONS AND MAY BE RELATED TO UNDERLYING PATIENT RELATED ISSUES. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT COMORBIDITIES, PHARMACOLOGICAL AND LESION CHARACTERISTICS. WITHOUT PROCEDURAL FILMS OR IMAGES FOR REVIEW THE REPORTED EVENT(S) COULD NOT BE CONFIRMED. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENTS ARE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. (B)(4). THIS REPORT IS A FOLLOW UP REPORT TO MFR NUMBER 9616099- 2016-00489 THAT WAS SUBMITTED UNDER THE PREVIOUS COMPLAINT HANDLING SOFTWARE SYSTEM. THE INFORMATION HAS BEEN DUPLICATED FROM THE FIRST REPORT WITH ADDITIONAL INFORMATION ADDED. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2017-00874 AND 1016427-2017-00875.
  •  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, BLOOD CLOTS, CLOTTING AND OCCLUSION OF THE INFERIOR VENA CAVA (IVCFILTER. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FROM (PPF) INDICATES THAT THE PATIENT HAD TWO FILTERS IMPLANTED TWENTY-ONE DAYS APART FROM EACH OTHER. THE FILTER, ALTHOUGH IT IS UNKNOWN WHICH, IS EMBEDDED IN THE WALL OF THE IVC. ACCORDING TO THE PPF, THE PATIENT HAD THE FIRST FILTER THAT WAS IMPLANTED REMOVED TWELVE DAYS POST IMPLANTATION. THE SECOND FILTER REMAINS IMPLANTED. THE PATIENT ALSO REPORTS TO BE SUFFERING FROM LEG PAIN, PAIN AT THE SITE OF THE IMPLANT, CRAMPING, NAUSEA, MENTAL ANGUISH AND DIZZINESS. SIX YEARS AND ELEVEN MONTHS POST THE FIRST IMPLANTATION, THE PATIENT PRESENTED TO THE HOSPITAL WITH A FILLING DEFECT AND BILATERAL DEEP VEIN THROMBOSIS. THE IVC AND THE ILIAC VEINS SHOWED A LACK OF BLOOD FLOW BELOW THE FILTER. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD A HISTORY OF ACUTE DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LEG AND WAS ADMITTED TO THE HOSPITAL FOR WORSENING OF THE DVT WHILE ON ANTICOAGULATION. THE PATIENT HAS COMPARTMENT SYNDROME. THE PATIENT ALSO HAD RECENTLY, PRIOR TO THE FIRST FILTER IMPLANTATION, UNDERGONE SURGERY AND HAD FASCIOTOMY WOUNDS AND HEMATOMAS. ORIGINALLY, THE PATIENT TOLERATED THE INDEX PROCEDURE WELL AND THE FILTER WAS SUCCESSFULLY DEPLOYED BELOW THE RENAL VEINS. FOR THE SECOND FILTER IMPLANTATION PROCEDURE, THE PATIENT DEVELOPED A PULMONARY EMBOLUS (PE) WHILE ON ANTICOAGULATION AND HAD A BLEED SECONDARY TO ANTICOAGULATION IN THE LEFT LEG. THE SECOND FILTER WAS ALSO SUCCESSFULLY DEPLOYED, THE PATIENT TOLERATED THE INDEX PROCEDURE WELL AND LEFT RECOVERY IN STABLE CONDITION.
  •  1.0
  •  2017-12-12
  •  466FXXXX
  •  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  •  466FXXXX
  •  UNK
  •  N
  •  *
  •  0HP
  •  HEALTH PROFESSIONAL
  •  DTK
  •  Filter, Intravascular, Cardiovascular
  •  CV
  •  Cardiovascular
  •  CV
  •  Cardiovascular
  •  2
  •  Devices subject to General Controls and Special Controls
  •  N
  •  Not Eligible for Accredited Persons Program
  •  1
  •  510(K)
  •  1
  •  2017-12-12
  •  1. L; 2. S