UNKNOWN
Report
- Report Number
- 3002808486-2015-00169
- Event Type
- Malfunction
- Date Received
- December 15, 2015
- Date of Event
- October 26, 2010
- Report Date
- August 10, 2017
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK CELECT FILTER AS CATALOG # IS UNKNOWN IT COULD BE EITHER K061815, K073374 OR K090140. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
(B)(4). CATALOG NUMBER UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK CELECT FILTER. AS CATALOG NUMBER IS UNKNOWN IT COULD BE EITHER K061815, K073374 OR K090140. INVESTIGATION IS STILL IN PROGRESS.
(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS REOPENED DUE TO PROVIDED ADDITIONAL INFORMATION STATING "TILT, VENA CAVA PERFORATION, AND THE INABILITY TO RETRIEVE THE DEVICE" 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 "TILT, VENA CAVA PERFORATION, AND THE INABILITY TO RETRIEVE THE DEVICE". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. FILTER TILT MAY HAPPEN DURING PLACEMENT OR DURING IMPLANTING PERIOD. FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. FROM THE PUBLISHED SCIENTIFIC LITERATURE FILTER TILT INSIDE IVC AND/OR EMBEDMENT OF FILTER LEGS OR FILTER HOOK IN THE IVC WALL IS A WELL-KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. 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.
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.
EXEMPTION NUMBER E2016032. WILLIAM COOK (B)(4) (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). 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 "TILT, VENA CAVA PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. 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.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2010". ADDITIONAL INFORMATION RECEIVED JANUARY 30, 2017: IT IS ALLEGED THAT PT SUFFERS FROM TILT, VENA CAVA PERFORATION, AND THE INABILITY TO RETRIEVE THE DEVICE. PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2010, AT (B)(6)." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2010". ADDITIONAL INFORMATION RECEIVED 30JAN2017: IT IS ALLEGED THAT PT SUFFERS FROM TILT, VENA CAVA PERFORATION, AND THE INABILITY TO RETRIEVE THE DEVICE. PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION.
THIS ADDITIONAL INFORMATION WAS RECEIVED ON 01/04/2016 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO PE AND HAD AN ATTEMPTED RETRIEVAL PERFORMED ON (B)(6) 2010. RETRIEVAL PROCEDURE NOTES STATE THAT MULTIPLE ATTEMPTS WERE MADE AT SNARING THE HOOK ON THE FILTER BUT WERE UNSUCCESSFUL. PLAINTIFF IS ALLEGING TILT, VENA CAVA PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 828237 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |