Example 1: Manufacturer report : Injury

Johnson & Johnson

CORDIS CASHEL

EI

reporter occupation: 100 OTHER HEALTH CARE PROFESSIONAL
MAUDE link: https://XXXXXX

dates

Report Date: 2017-12-02
Event Date: 2014-03-13
Mfr Rec’d Date: 2017-11-03
FDA Rec’d Date: 2017-12-02
Date Added: 2017-12-02
Date Changed: 2017-12-31

device

  • product code: DQO
  • device name: Catheter, Intravascular, Diagnostic
  • brand: TRAPEASE PVCF FEM/JUG 55CM CSI
  • generic: CATHETER, INTRAVASCULAR, DIAGNOSTIC
  • operator: 0HP HEALTH PROFESSIONAL
  • model #:
  • catalog #: 466P306AU
  • lot #: R0407457
  • other ID #:
  • evaluated by manufacturer: *
  • available: N
  • expires:
  • PMA/510K #:

description

AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING BUT NOT LIMITED TO, FRACTURE, MIGRATION OF ENTIRE FILTER TO HEART, PERFORATION OF FILTER STRUTS INTO VENA CAVA AND ORGANS, TILT, FILTER EMBEDDED IN WALL OF THE INFERIOR VENA CAVA ( IVC ), REQUIRING EMERGENCY OPEN-HEART SURGERY. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES. REQUIRING EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN, SUFFERING AND OTHER DAMAGES. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FROM (PPF) INDICATES THAT SIX YEARS AND TWO MONTHS POST IMPLANTATION, ASIDE FROM THE ABOVE MENTIONED MALFUNCTIONS, THE PATIENT HAD BLOOD CLOTS, CLOTTING, THROMBOSIS IN THE FILTER AND OCCLUSION OF THE IVC . THE PATIENT ALSO REPORTED EMOTIONAL AND PHYSICAL PAIN AND SUFFERING. PRIOR TO THE REMOVAL ATTEMPT, THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH, CHEST DISCOMFORT, AND DIZZINESS FOR SEVERAL WEEKS BEFORE PRESENTING TO THE ER WITH INCREASED PAIN IN THE RIGHT ARM.

other elements

  •  7077672
  •  1016427-2017-00857
  •  Y
  •  Y
  •  Y
  •  2017-12-02
  •  2014-03-13
  •  N
  •  Y
  •  2017-11-03
  •  2007-04-26
  •  Y
  •  I
  •  2017-12-02
  •  2017-12-31
  •  IN
  •  Injury
  •  M
  •  Manufacturer report
  •  100
  •  OTHER HEALTH CARE PROFESSIONAL
  •  I
  •  *
  •  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 A TRAPEASE INFERIOR VENA CAVA (IVCFILTER. THE INDICATION FOR FILTER PLACEMENT WAS NOT REPORTED. THERE IS NO AVAILABLE INFORMATION REGARDING THE IMPLANTATION PROCEDURE. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING BUT NOT LIMITED TO, FRACTURE, MIGRATION OF ENTIRE FILTER TO HEART, PERFORATION OF FILTER STRUTS INTO VENA CAVA AND ORGANS, TILT, FILTER EMBEDDED IN WALL OF THE INFERIOR VENA CAVA (IVC), REQUIRING EMERGENCY OPEN-HEART SURGERY. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES. REQUIRING EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN, SUFFERING AND OTHER DAMAGES. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FROM (PPF) INDICATES THAT SIX YEARS AND TWO MONTHS POST IMPLANTATION, ASIDE FROM THE ABOVE MENTIONED MALFUNCTIONS, THE PATIENT HAD BLOOD CLOTS, CLOTTING, THROMBOSIS IN THE FILTER AND OCCLUSION OF THE IVC. THE PATIENT ALSO REPORTED EMOTIONAL AND PHYSICAL PAIN AND SUFFERING. PRIOR TO THE REMOVAL ATTEMPT, THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH, CHEST DISCOMFORT, AND DIZZINESS FOR SEVERAL WEEKS BEFORE PRESENTING TO THE ER WITH INCREASED PAIN IN THE RIGHT ARM. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE TRAPEASE 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. WITHOUT IMAGES OR PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER TILT, MIGRATION AND FRACTURE COULD NOT BE CONFIRMED AND THE EXACT CAUSES COULD NOT BE DETERMINED. INFERIOR VENA CAVA (IVCFILTER MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTER IMPLANTS AND IS LISTED IN THE INSTRUCTION FOR USE (IFU) AS SUCH. POSSIBLE CAUSES FOR FILTER MIGRATION INCLUDES MEGA CAVA, WIRE ENTRAPMENT DURING CENTRAL VENOUS CATHETER PLACEMENT, �SAIL� EFFECT (CRANIAL MIGRATION) OF LARGE CLOT BURDEN WITHIN THE FILTER, MECHANICAL DEVICE FAILURE, AND OPERATOR ERROR. PHYSIOLOGIC CAUSES OF MIGRATION MAY RESULT FROM TEMPORARY DYSMORPHISM OF THE INFERIOR VENA CAVA INCLUDING BENDING, COUGHING OR VALSALVA MANEUVERS RESULTING IN DISLODGMENT OF THE FILTER. SOME STUDIES SUGGEST THAT STRENUOUS PHYSICAL ACTIVITY AND INCREASED INTRA-ABDOMINAL PRESSURE CAN LEAD TO MIGRATION OF IVC FILTERS. THE TIMING AND MECHANISM OF THE TILT HAS NOT BEEN REPORTED AT THIS TIME. THE INSTRUCTIONS FOR USE (IFU) STATES FILTER FRACTURE IS A POTENTIAL COMPLICATION OF VENA CAVA FILTERS. ANATOMIC LOCATIONS THAT CREATE CONCENTRATED STRESS POINTS FROM FILTER DEFORMATION (FOR EXAMPLE, DEPLOYMENT AT APEX OF SCOLIOSIS, OVERLAPPING OF EITHER OF THE RENAL OSTIA, OR PLACEMENT ADJACENT TO A VERTEBRAL OSTEOPHYTE) MAY CONTRIBUTE TO FRACTURE OF A PARTICULAR FILTER STRUT. 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. THE BRIEF ALSO REPORTED PERFORATION OF THE IVC; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. IT IS UNKNOWN IF THE TILT CONTRIBUTED TO THE REPORTED PERFORATION. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. ANXIETY, PAIN AND SHORTNESS OF BREATH DO NOT REPRESENT DEVICE MALFUNCTIONS AND MAY BE RELATED TO UNDERLYING PATIENT RELATED ISSUES. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, 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. THIS REPORT IS A FOLLOW UP REPORT TO MFR NUMBER 9616099-2016-00272 THAT WAS SUBMITTED UNDER THE PREVIOUS COMPLAINT HANDLING SOFTWARE SYSTEM. THE INFORMATION HAS BEEN DUPLICATED FROM THE FIRST REPORT WITH ADDITIONAL INFORMATION ADDED.
  •  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING BUT NOT LIMITED TO, FRACTURE, MIGRATION OF ENTIRE FILTER TO HEART, PERFORATION OF FILTER STRUTS INTO VENA CAVA AND ORGANS, TILT, FILTER EMBEDDED IN WALL OF THE INFERIOR VENA CAVA (IVC), REQUIRING EMERGENCY OPEN-HEART SURGERY. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES. REQUIRING EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN, SUFFERING AND OTHER DAMAGES. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FROM (PPF) INDICATES THAT SIX YEARS AND TWO MONTHS POST IMPLANTATION, ASIDE FROM THE ABOVE MENTIONED MALFUNCTIONS, THE PATIENT HAD BLOOD CLOTS, CLOTTING, THROMBOSIS IN THE FILTER AND OCCLUSION OF THE IVC. THE PATIENT ALSO REPORTED EMOTIONAL AND PHYSICAL PAIN AND SUFFERING. PRIOR TO THE REMOVAL ATTEMPT, THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH, CHEST DISCOMFORT, AND DIZZINESS FOR SEVERAL WEEKS BEFORE PRESENTING TO THE ER WITH INCREASED PAIN IN THE RIGHT ARM.
  •  1.0
  •  2017-12-02
  •  TRAPEASE PVCF FEM/JUG 55CM CSI
  •  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  •  466P306AU
  •  R0407457
  •  N
  •  *
  •  0HP
  •  HEALTH PROFESSIONAL
  •  DQO
  •  Catheter, Intravascular, Diagnostic
  •  CV
  •  Cardiovascular
  •  CV
  •  Cardiovascular
  •  2
  •  Devices subject to General Controls and Special Controls
  •  P
  •  Eligible for Accredited Persons Expansion Pilot Program
  •  1
  •  510(K)
  •  1
  •  2017-12-02
  •  1. H; 2. L; 3. R; 4. S