COOK CELECT FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2016-01199
- Event Type
- Death
- Date Received
- October 11, 2016
- Date of Event
- September 10, 2014
- Report Date
- September 26, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K073374
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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). COOK INC./ WILLIAM COOK EUROPE IS NOT ASSUMING RESPONSIBILITY FOR PATIENT DEATH. THE CAUSE OF DEATH IS UNCLEAR. (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. THE PATIENT INVOLVED WAS REPORTED TO BE DECEASED WITHOUT FURTHER DETAILS, THEREFORE THIS REPORT IS BEING SUBMITTED AS ¿DEATH¿ RELATED AS A CAUTIONARY MEASURE. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION. 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.
ADDITIONAL INFORMATION: INVESTIGATION: THE FOLLOWING FIELDS WERE UPDATED PER ADDITIONAL INFORMATION RECEIVED: EVENT OR PROBLEM, RELEVANT TESTS, EVENT OR PROBLEM CODES. CONCLUSION CODE(S): APPROPRIATE TERM/CODE NOT AVAILABLE (4316) WAS SELECTED BECAUSE THE PREVIOUS INVESTIGATION REMAINS UNCHANGED BY THE ADDITIONAL INFORMATION. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. PER QUALITY ENGINEERING REVIEW, THE ADDITIONAL INFORMATION PROVIDED FOR THIS COMPLAINT DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSION. THEREFORE, NO NEW INVESTIGATION ACTIVITIES WILL BE CONDUCTED AT THIS TIME. COOK WILL REOPEN THE INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
MANUFACTURER REFERENCE #(B)(4). EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). H11) CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: B1: ADVERSE EVENT AND PRODUCT PROBLEM TO ADVERSE EVENT. COMPLAINT WAS REOPENED SINCE LOT# WAS PROVIDED. HOWEVER, SINCE THIS IS THE ONLY ADDITIONAL INFORMATION RECEIVED THE BELOW INVESTIGATION INFORMATION IS STILL VALID AND REMAINS UNCHANGED: PATIENT'S MEDICAL RECORDS ARE UNKNOWN AT THIS TIME AND NO IMAGING IS PROVIDED. THEREFORE, IT IS IMPOSSIBLE TO COMMENT ON THE REPORTED LEG PAIN AND DEATH OF THE PATIENT MORE THAN 4 YEARS AFTER FILTER PLACEMENT. ALSO, IT IS IMPOSSIBLE TO COMMENT ON AUTOPSY REVEALING "MASSIVE BILATERAL ACUTE PULMONARY EMBOLISM; DEEP VENOUS THROMBOSIS AND COMPLETE OCCLUSION OF THE LEFT ILIAC VEIN; AND A RECENT PRE-MORTEM THROMBUS WITHIN THE IVC FILTER." BASED ON THE LIMITED INFORMATION AVAILABLE IN THIS COMPLAINT, IT REMAINS UNKNOWN IF THE FILTER PERFORMANCE WAS RELATED TO THIS OCCURRENCE AND THEREFORE THE EXACT ROOT CAUSE IS UNKNOWN. HOWEVER, PE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, IT IS REPORTED THAT THE PULMONARY EMBOLISM IN SOME CASES MAY ORIGINATE FROM UPPER EXTREMITIES INSTEAD OF LOWER EXTREMITY VEINS. 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.
THIS ADDITIONAL INFORMATION WAS RECEIVED ON 04/28/2017 AS FOLLOWS: THE PATIENT ALLEGEDLY RECEIVED THE FILTER IMPLANT ON (B)(6) 2009 FOR DVT. THE PATIENT DIED ON (B)(6) 2014. THE PATIENT¿S ESTATE ALLEGES DEATH DUE TO CAVAL THROMBUS, DVT OF LEFT ILIAC VEIN, AND MASSIVE BILATERAL PE.
DEATH CERTIFICATE RECEIVED, NO ADDITIONAL INFORMATION.
(B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374 OR K090140. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: PATIENT'S MEDICAL RECORDS ARE UNKNOWN AT THIS TIME AND NO IMAGING IS PROVIDED. THEREFORE, NO CONCLUSION CAN BE DRAWN BASED ON THE INCOMPLETE INFORMATION PROVIDED REGARDING THE LEG PAIN AND DEATH OF THE PATIENT MORE THAN 4 YEARS AFTER FILTER PLACEMENT, NOR ON AUTOPSY REVEALING "MASSIVE BILATERAL ACUTE PULMONARY EMBOLISM; DEEP VENOUS THROMBOSIS AND COMPLETE OCCLUSION OF THE LEFT ILIAC VEIN; AND A RECENT PRE-MORTEM THROMBUS WITHIN THE IVC FILTER." BASED ON THE LIMITED INFORMATION AVAILABLE IN THIS COMPLAINT, IT REMAINS UNKNOWN IF THE FILTER PERFORMANCE WAS RELATED TO THIS OCCURRENCE AND THEREFORE THE EXACT ROOT CAUSE IS UNKNOWN. HOWEVER, PE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, IT IS REPORTED THAT THE PULMONARY EMBOLISM IN SOME CASES MAY ORIGINATE FROM UPPER EXTREMITIES INSTEAD OF LOWER EXTREMITY VEINS. 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. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2009 PRIOR TO A SPINAL PROCEDURE." "ON OR ABOUT (B)(6) 2014, [PT] COMPLAINING OF LEG PAIN, WHILE WALKING. THERE, HE WAS ADMITTED AND FOUND TO HAVE SYMPTOMS CONSISTENT WITH NEUROGENIC CLAUDICATION LIKELY SECONDARY TO AN EXACERBATION OF HIS LUMBAR SPINAL STENOSIS. PAIN MANAGEMENT AND PHYSICAL THERAPY WAS STARTED. AFTER A PHYSICAL THERAPY SESSION, THE [PT] BECAME UNEXPECTEDLY LIGHTHEADED WHILE CLIMBING THE STAIRS. HE THEN BECAME UNRESPONSIVE AND ULTIMATELY DIED ON (B)(6) 2014." "THE FINAL PATHOLOGIC FINDINGS OF AN AUTOPSY PERFORMED AT THE (B)(6) REVEALED MASSIVE BILATERAL ACUTE PULMONARY EMBOLISM; DEEP VENOUS THROMBOSIS AND COMPLETE OCCLUSION OF THE LEFT ILIAC VEIN; AND A RECENT PRE-MORTEM THROMBUS WITHIN THE IVC FILTER." PATIENT OUTCOME: PATIENT DECEASED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 667514 | COOK CELECT FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death |