UNKNOWN
Report
- Report Number
- 3002808486-2017-00794
- Event Type
- Death
- Date Received
- March 14, 2017
- Report Date
- October 9, 2017
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- ATTORNEY
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). A2) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A4) UNKNOWN AS INFORMATION WAS NOT PROVIDED. B3) UNKNOWN AS INFORMATION WAS NOT PROVIDED. D1) UNKNOWN AS INFORMATION WAS NOT PROVIDED. D4) LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG#: UNKNOWN BUT REFERRED TO AS AN IVC FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. D6) UNKNOWN AS INFORMATION WAS NOT PROVIDED. D7) UNKNOWN AS INFORMATION WAS NOT PROVIDED. F9) UNKNOWN AS LOT# IS UNKNOWN. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. H4) UNKNOWN AS LOT# IS UNKNOWN. (B)(4). IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION AFTER FURTHER INFORMATION IS RECEIVED AND WILL SUPPLEMENT IN ACCORDANCE WITH 21 C.F.R.803.56 WHEN APPROPRIATE. IT IS UNKNOWN, IF REPORTED PATIENT DEATH IN ANY WAY RELATED TO THE FILTER. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. CORRECTION: B1,B2,H1. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING ¿IVC FILTER IMPLANTED". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. UNKNOWN IF REPORTED PATIENT DEATH IS RELATED TO FILTER. CATALOG # AND LOT# ARE UNKNOWN. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH AN IVC FILTER AND SUFFERED PRE-DEATH INJURIES AND/OR DEATH." PATIENT OUTCOME: ALLEGED THAT [PT] "HAVE SUFFERED PERMANENT AND CONTINUOUS INJURIES, PAIN AND SUFFERING, DISABILITY AND IMPAIRMENT. [PT] HAVE SUFFERED EMOTIONAL TRAUMA, HARM AND INJURIES THAT WILL CONTINUE INTO THE FUTURE. [PT] HAVE LOST THEIR ABILITY TO LIVE A NORMAL LIFE, AND WILL CONTINUE TO BE SO DIMINISHED INTO THE FUTURE. FURTHERMORE, [PT] HAVE LOST EARNINGS AND WILL CONTINUE TO LOSE EARNINGS INTO THE FUTURE AND HAVE MEDICAL BILLS BOTH PAST AND FUTURE RELATED TO CARE BECAUSE OF THE IVC FILTERS¿ DEFECTS." [PT] IS DECEASED. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS AN IVC FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. (B)(4). THE PATIENT INVOLVED WAS REPORTED TO BE DECEASED, BUT IT HAS NOT BEEN INDICATED THAT THE IVC FILTER ATTRIBUTED TO THIS OUTCOME. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: ADVERSE EVENT TO PRODUCT PROBLEM, DEATH TO MALFUNCTION. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH AN IVC FILTER AND SUFFERED PRE-DEATH INJURIES AND/OR DEATH." PATIENT OUTCOME: ALLEGED THAT [PT] "HAVE SUFFERED PERMANENT AND CONTINUOUS INJURIES, PAIN AND SUFFERING, DISABILITY AND IMPAIRMENT. [PT] HAVE SUFFERED EMOTIONAL TRAUMA, HARM AND INJURIES THAT WILL CONTINUE INTO THE FUTURE. [PT] HAVE LOST THEIR ABILITY TO LIVE A NORMAL LIFE, AND WILL CONTINUE TO BE SO DIMINISHED INTO THE FUTURE. FURTHERMORE, [PT] HAVE LOST EARNINGS AND WILL CONTINUE TO LOSE EARNINGS INTO THE FUTURE AND HAVE MEDICAL BILLS BOTH PAST AND FUTURE RELATED TO CARE BECAUSE OF THE IVC FILTERS¿ DEFECTS." [PT] IS DECEASED. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
THIS ADDITIONAL INFORMATION RECEIVED ON 09/22/2017 AS FOLLOWS: PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012. PATIENT IS ALLEGING NO ADVERSE EVENTS RELATED TO THE DEVICE. THE PATIENT INVOLVED WAS REPORTED TO BE DECEASED, BUT IT HAS NOT BEEN INDICATED THAT THE IVC FILTER ATTRIBUTED TO THIS OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186259 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |