GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2018-01451
- Event Type
- Death
- Date Received
- December 13, 2018
- Date of Event
- July 17, 2016
- Report Date
- March 20, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K090140
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS REPORTED THAT THE PATIENT DIED WITHIN 2 MONTHS AFTER FILTER PLACEMENT. THE CAUSE OF DEATH IS UNKNOWN, BUT "POSSIBLY RELATED TO THE DEVICE." NO PRODUCT WAS RETURNED AND NO IMAGING WAS PROVIDED. THEREFORE, IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE DEATH AND IF IT HAD ANY RELATION TO THE FILTER, BUT THE COMPLAINT WILL BE REOPENED IN CASE ADDITIONAL INFORMATION SHOULD BE PROVIDED. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO STUDY: PATIENT WAS CONSENTED IN PRESERVE AND HAD THE GÜNTHER-TULIP¿ VENA CAVA FILTER SYSTEM SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2017 THE SITE LEARNED THE PATIENT EXPIRED ON (B)(6) 2016. NO CAUSE OF DEATH AVAILABLE. UNKNOWN CAUSE OF DEATH WAS CONSIDERED POSSIBLY RELATED TO THE DEVICE. PATIENT OUTCOME: PATIENT DIED (B)(6) 2016.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 998788 | GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E3438979 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Death |