Example 2: Manufacturer report : Injury

Johnson & Johnson

CORDIS CASHEL

CO. TIPPERARY EI

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

dates

Report Date: 2017-12-19
Event Date: 2017-11-27
Mfr Rec’d Date: 2017-11-27
FDA Rec’d Date: 2017-12-19
Date Added: 2017-12-19
Date Changed: 2017-12-25

device

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

description

AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF THE OPTEASE VENA CAVA FILTER . THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, FRACTURE, EMBEDMENT OF THE FILTER TO THE WALL OF THE IVC , MIGRATION, AND MULTIPLE PERFORATIONS OF THE IVC WALL. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-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 MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES.

other elements

  •  7130208
  •  1016427-2017-00885
  •  Y
  •  Y
  •  Y
  •  2017-12-19
  •  2017-11-27
  •  N
  •  N
  •  2017-11-27
  •  Y
  •  I
  •  2017-12-19
  •  2017-12-25
  •  IN
  •  Injury
  •  M
  •  Manufacturer report
  •  000
  •  OTHER
  •  N
  •  No
  •  *
  •  No answer provided
  •  I
  •  Initial submission
  •  OTHER
  •  OTHER
  •  I
  •  Johnson & Johnson
  •  CORDIS CASHEL
  •  CAHIR ROAD
  •  CASHEL
  •  CO. TIPPERARY
  •  EI
  •  THE EXACT IMPLANT DATE IS UNKNOWN. THE CATALOG NUMBER IS UNKNOWN, IF RECEIVED IT WILL BE PROVIDED. COMPLAINT CONCLUSION: AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF THE OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, FRACTURE, EMBEDMENT OF THE FILTER TO THE WALL OF THE IVC, MIGRATION, AND MULTIPLE PERFORATIONS OF THE INFERIOR VENA CAVA (IVC) WALL. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-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 MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT 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. WITHOUT IMAGES OR PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER FRACTURE, MIGRATION AND PERFORATION OF THE IVC WALL COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. 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. INFERIOR VENA CAVA (IVCFILTER MIGRATION IS ALSO 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 INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. THE LEGAL BRIEF ALSO NOTED THAT THE FILTER WAS EMBEDDED IN THE WALL OF THE IVC. ENDOTHELIALIZATION, REMODELING/RESTRUCTURING OF THE VESSEL WALL FOLLOWING DEVICE IMPLANTATION, IS THE BODY�S NATURAL RESPONSE AND HAS BEEN SHOWN TO OCCUR IN AS SHORT A PERIOD AS 12 DAYS. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.
  •  AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF THE OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, FRACTURE, EMBEDMENT OF THE FILTER TO THE WALL OF THE IVC, MIGRATION, AND MULTIPLE PERFORATIONS OF THE IVC WALL. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-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 MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES.
  •  1.0
  •  2017-12-19
  •  466FXXXX
  •  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  •  466FXXXX
  •  466FXXXX
  •  UNK
  •  N
  •  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
  •  2017-12-19
  •  1. L