STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
Report
- Report Number
- 2134265-2013-03031
- Event Type
- Death
- Date Received
- May 14, 2013
- Report Date
- April 15, 2013
- Manufacturer
- BOSTON SCIENTIFIC - CORK
- Product Code
- DTK
- PMA / PMN Number
- K955396
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
BRAND NAME CHANGED FROM GREENFIELD TO STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0 MM INTRODUCER SYSTEM. PMA# OR 510K# CHANGED FROM K964284 TO K955396. (B)(4).
(B)(4). PMA# OR 510K# CORRECTED FROM K901659 TO K964284. (B)(4).
DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
QUESTION 1: PLEASE PROVIDE ANY EVALUATION OF OTHER INFORMATION USED BY YOUR FIRM TO DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE. RESPONSE: BSC¿S INVESTIGATION INCLUDED A REVIEW OF SIMILAR COMPLAINT TRENDS, BSC¿S MEDICAL REVIEW ASSESSMENT, PRODUCT FAMILY TRENDS, DIRECTIONS FOR USE, LABELING AND DEATH CERTIFICATE TO DETERMINE IF THE REPORTED EVENT WAS OR WAS NOT ATTRIBUTABLE TO THE DEVICE. BSC MEDICAL REVIEW OF THE EVENT OF EROSION/PERFORATION OF URETER FOUND THAT ALL AVAILABLE DATA REASONABLY SUGGESTS THAT THE EVENT IS ANTICIPATED IN NATURE AND SEVERITY PER THE DEVICES DIRECTIONS FOR USE (DFU) AND CLINICAL EXPERIENCE SUMMARY. HOWEVER, THERE IS NOT ENOUGH INFORMATION AVAILABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE USE OF THE DEVICE AND THE GASTROINTESTINAL BLEED AND PATIENT'S DEATH. THE REPORTED COMPLAINT WAS ASSIGNED A ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATION, WHICH INDICATES THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DFU AND/OR DEVICE LABELING; THUS, A DEVICE-RELATED ROOT CAUSE DOES NOT APPLY. THE DEVICE¿S DFU INDICATE MOVEMENT OR MIGRATION OF THE FILTER AND PERFORATION OF THE VENA CAVA, ADJACENT BLOOD VESSELS OR ORGAN BY ONE OR MORE HOOKS AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF VENA CAVA FILTERS. QUESTION 2: PLEASE PROVIDE ALL RELEVANT INFORMATION WHICH YOUR FIRM USED TO DETERMINE THAT THE REPORTED EVENT IS OCCURRING WITH GREATER OR LESSER FREQUENCY AND/OR SEVERITY, THAN IS STATED IN THE LABELING FOR THE DEVICE, OR EXPECTED (I.E. WHERE THE DEVICE LABELING IS SILENT ON EVENT FREQUENCY AND SEVERITY). IN YOUR RESPONSE, PLEASE PROVIDE THE EXPECTED AND OBSERVED FREQUENCY AND SEVERITY FOR THE REPORTED EVENT WITH THIS DEVICE AND, AS APPLICABLE, THE FAMILY OF DEVICES IT BELONGS TO. RESPONSE: A REVIEW WAS CONDUCTED FOR GREENFIELD STAINLESS STEEL VENA CAVA FILTER DEVICE FILTER BROKEN COMPLAINTS REPORTED WORLDWIDE FROM (B)(4) 2012 THROUGH (B)(4) 2013. (B)(4). A REVIEW OF THE DEVICE RISK DOCUMENTATION CONFIRMED THAT THE REPORTED FILTER BROKEN EVENT IS AN ANTICIPATED POTENTIAL FAILURE MODE ASSOCIATED WITH THIS DEVICE. THE SEVERITY OF THE REPORTED EVENT IS CONSISTENT WITH THE ANTICIPATED POTENTIAL SEVERITY OUTLINED IN THE DEVICE RISK DOCUMENTATION OF MAJOR VESSEL TRAUMA. (B)(4). THE RISK REVIEW CONFIRMED THAT THE COMBINED SEVERITY AND FREQUENCY RANKINGS ARE CONSISTENT WITH THE RISK LEVEL DOCUMENTED IN THE DEVICE RISK DOCUMENTATION. BSC WILL CONTINUE TO MONITOR AND TREND THESE COMPLAINTS AND THE ASSOCIATED RISKS AS OUTLINED IN OUR QUALITY SYSTEMS PROCESS. QUESTION 3: PLEASE PROVIDE THE DATE OF THE EVENT OR THE TIME INTERVAL BETWEEN THE FILTER IMPLANTATION AND EVENT OCCURRED. RESPONSE: THE COMPLAINT DEVICE WAS IMPLANTED ON (B)(6) 1998 AND THE PATIENT EXPIRED (B)(6) 2011. (B)(4).
IT WAS REPORTED THAT A POST-PROCEDURE DEATH OCCURRED. THE PATIENT HAD A GREENFIELD VENA CAVA FILTER IMPLANTED AT AN UNKNOWN TIME AND DIED. THE CAUSE OF DEATH WAS LISTED AS GASTROINTESTINAL BLEED AND HYPOVOLEMIC SHOCK.
IT WAS FURTHER REPORTED THAT THE STAINLESS STEEL GREENFIELD VENA CAVA FILTER WAS IMPLANTED IN THE INFERIOR VENA CAVA. "OVER TIME, THE FILTER ERODED, FRAGMENTED AND THEN MIGRATED THROUGH THE INFERIOR VENA CAVA INTO HER RIGHT URETER AND THEN PERFORATED THE SMALL BOWEL CAUSING A MASSIVE BLEEDING EVENT" WHICH THEN "LED TO A CATASTROPHIC DROP IN BLOOD PRESSURE, HYPOVOLEMIC SHOCK AND ORGAN FAILURE" LEADING TO THE PATIENT'S DEATH.
IT WAS FURTHER REPORTED THAT THE STAINLESS STEEL GREENFIELD VENA CAVA FILTER WAS IMPLANTED IN THE INFERIOR VENA CAVA. "OVER TIME, THE FILTER ERODED, FRAGMENTED AND THEN MIGRATED THROUGH THE INFERIOR VENA CAVA INTO HER RIGHT URETER AND THEN PERFORATED THE SMALL BOWEL CAUSING A MASSIVE BLEEDING EVENT" WHICH THEN "LED TO A CATASTROPHIC DROP IN BLOOD PRESSURE, HYPOVOLEMIC SHOCK AND ORGAN FAILURE" LEADING TO THE PATIENT'S DEATH.
IT WAS FURTHER REPORTED THAT THE STAINLESS STEEL GREENFIELD VENA CAVA FILTER WAS IMPLANTED IN THE INFERIOR VENA CAVA. "OVER TIME, THE FILTER ERODED, FRAGMENTED AND THEN MIGRATED THROUGH THE INFERIOR VENA CAVA INTO HER RIGHT URETER AND THEN PERFORATED THE SMALL BOWEL CAUSING A MASSIVE BLEEDING EVENT" WHICH THEN "LED TO A CATASTROPHIC DROP IN BLOOD PRESSURE, HYPOVOLEMIC SHOCK AND ORGAN FAILURE" LEADING TO THE PATIENT'S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212928 | STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM | FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | BOSTON SCIENTIFIC - CORK | UNK140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |