Example 3: Manufacturer report : Injury

Johnson & Johnson

CORDIS CASHEL

CASHEL, CO. TIPPERARY EI

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

dates

Report Date: 2017-12-28
Event Date: 2017-12-07
Mfr Rec’d Date: 2017-12-07
FDA Rec’d Date: 2017-12-28
Date Added: 2017-12-28
Date Changed: 2017-12-31

device

  • product code: DQO
  • device name: Catheter, Intravascular, Diagnostic
  • brand: UNKNOWN VENA CAVA FILTER
  • generic: CATHETER, INTRAVASCULAR, DIAGNOSTIC
  • operator: 0HP HEALTH PROFESSIONAL
  • model #:
  • catalog #: 466P306X
  • lot #: UNK
  • other ID #:
  • evaluated by manufacturer: *
  • available: N
  • expires:
  • PMA/510K #:

description

AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF EITHER DEFENDANT�S TRAPEASE VENA CAVA FILTER APPROXIMATELY TEN YEARS POST IMPLANTATION THE PATIENT UNDERWENT AN UPDATED CT SCAN WHICH REVEALED THAT THE FILTER HAD SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, THE FILTER WAS SIGNIFICANTLY TILTED, THE FILTER HAD MIGRATED, ONE STRUT WAS BENT, ONE STRUT HAD FRACTURED, THE TIP OF THE FILTER WAS EMBEDDED IN THE ANTERIOR WALL OF THE INFERIOR VENA CAVA ( IVC ) AND AT LEAST FOUR STRUTS WERE SIGNIFICANTLY PERFORATING THE IVC . AS A DIRECT AND PROXIMATE RESULT OF THE MALFUNCTIONS, THE PATIENT SUFFERED AND CONTINUES TO SUFFER LIFE-THREATENING INJURIES AND DAMAGES, WHICH REQUIRED AND WILL CONTINUE TO REQUIRE EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

other elements

  •  7150639
  •  1016427-2017-00922
  •  Y
  •  Y
  •  Y
  •  2017-12-28
  •  2017-12-07
  •  N
  •  N
  •  2017-12-07
  •  Y
  •  I
  •  2017-12-28
  •  2017-12-31
  •  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
  •  DEVICE REMAINS IMPLANTED. AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. APPROXIMATELY TEN YEARS POST IMPLANTATION THE PATIENT UNDERWENT AN UPDATED CT SCAN WHICH REVEALED THAT THE FILTER HAD SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, THE FILTER WAS SIGNIFICANTLY TILTED, THE FILTER HAD MIGRATED, ONE STRUT WAS BENT, ONE STRUT HAD FRACTURED, THE TIP OF THE FILTER WAS EMBEDDED IN THE ANTERIOR WALL OF THE INFERIOR VENA CAVA (IVC) AND AT LEAST FOUR STRUTS WERE SIGNIFICANTLY PERFORATING THE IVC. AS A DIRECT AND PROXIMATE RESULT OF THE MALFUNCTIONS, THE PATIENT SUFFERED AND CONTINUES TO SUFFER LIFE-THREATENING INJURIES AND DAMAGES, WHICH REQUIRED AND WILL CONTINUE TO REQUIRE EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, 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. WITHOUT IMAGES OR PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER TILT, MIGRATION, FRACTURE AND PERFORATION COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. THE TIMING AND MECHANISM OF THE REPORTED FILTER TILT COULD NOT BE DETERMINED. 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. 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 IVCFILTERS. THE BRIEF ALSO MENTIONED THAT THE TIP OF THE FILTER WAS EMBEDDED. ENDOTHELIALIZATION, REMODELING/RESTRUCTURING OF THE INTERNAL LUMEN 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 BRIEF, THE PATIENT UNDERWENT PLACEMENT OF EITHER DEFENDANT�S TRAPEASE VENA CAVA FILTER APPROXIMATELY TEN YEARS POST IMPLANTATION THE PATIENT UNDERWENT AN UPDATED CT SCAN WHICH REVEALED THAT THE FILTER HAD SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, THE FILTER WAS SIGNIFICANTLY TILTED, THE FILTER HAD MIGRATED, ONE STRUT WAS BENT, ONE STRUT HAD FRACTURED, THE TIP OF THE FILTER WAS EMBEDDED IN THE ANTERIOR WALL OF THE INFERIOR VENA CAVA (IVC) AND AT LEAST FOUR STRUTS WERE SIGNIFICANTLY PERFORATING THE IVC. AS A DIRECT AND PROXIMATE RESULT OF THE MALFUNCTIONS, THE PATIENT SUFFERED AND CONTINUES TO SUFFER LIFE-THREATENING INJURIES AND DAMAGES, WHICH REQUIRED AND WILL CONTINUE TO REQUIRE EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.
  •  1.0
  •  2017-12-28
  •  UNKNOWN VENA CAVA FILTER
  •  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  •  466P306X
  •  UNK
  •  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
  •  2017-12-28
  •  1. H; 2. L; 3. S