UNKNOWN
Report
- Report Number
- 3002808486-2016-00576
- Event Type
- Malfunction
- Date Received
- June 22, 2016
- Date of Event
- February 19, 2013
- Report Date
- May 9, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
(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. INVESTIGATION IS STILL IN PROGRESS.
(B)(4). CATALOG NUMBER: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG NUMBER IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: PATIENTS MEDICAL RECORDS ARE UNKNOWN AND NO IMAGING IS PROVIDED. THEREFORE, IT IS NOT POSSIBLE TO COMMENT ON THE SIGNIFICANT PHYSICAL PERSONAL INJURIES DIRECTLY AND PROXIMATELY CAUSED BY THE IVC FILTER, WHICH PATIENT ALLEGEDLY SUFFERED APPROX. 3 MONTHS AFTER PLACEMENT OF A CELECT FILTER, BECAUSE THE FILTER BECAME "IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATING [PT], AND/OR OTHERWISE BECOMING IRRETRIEVABLE." ALSO, IT IS NOT POSSIBLE TO COMMENT ON THE MEDICAL EXPENSES, WHICH PATIENT ALLEGEDLY HAS INCURRED AND WILL INCUR IN THE FUTURE, THE PAIN AND SUFFERING AND LOSS OF ENJOYMENT OF LIFE, THE PATIENT HAS ENDURED AND WILL ENDURE, AS WELL AS THE PATIENT OTHERWISE BEING DAMAGED IN A PERSONAL AND PECUNIARY NATURE. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING FILTER PLACEMENT OR DURING FILTER IMPLANTING PERIOD. UNDER NORMAL CONDITIONS, I.E. IVC < 30 MM, THE RADIAL FORCE OF THE FILTER WILL ENSURE PROPER ATTACHMENT OF THE FILTER LEGS TO IVC. HOWEVER, FILTER MIGRATION IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. MANIPULATION IN THE AREA OF THE FILTER IMPLANT OR A BLOOD CLOT CAPTURED INSIDE THE FILTER MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. 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. RPN AND LOT NUMBER ARE UNKNOWN, BUT THERE IS 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.
EXEMPTION NUMBER E2016032. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
EXEMPTION NUMBER E2016032. (B)(4). INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. 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 'CELECT-TILT, VC PERFORATION, UNABLE TO BE RETRIEVED, EMBEDMENT, LIFETIME ANTICOAGULATION, PAIN, ANXIETY'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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. A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. 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. 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. UNKNOWN IF THE REPORTED PAIN IS DIRECTLY RELATED TO THE FILTER. UNKNOWN IF THE REPORTED LIFETIME ANTICOAGULANT AND ANXIETY ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. CATALOG AND LOT# ARE UNKNOWN, BUT THE CELECT FILTER IS MANUFACTURED AND INSPECTED ACCORDING TO MANUFACTURING INSTRUCTIONS. 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 OF EVENT ACCORDING TO COMPLAINANT: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2012. IN OR AROUND (B)(6) 2013, [PT] SUFFERED SIGNIFICANT PHYSICAL PERSONAL INJURIES DIRECTLY AND PROXIMATELY CAUSED BY THE AFOREMENTIONED IVC FILTER BECOMING IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATING [PT], AND/OR OTHERWISE BECOMING IRRETRIEVABLE." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2012. IN OR AROUND (B)(6) 2013, [PT] SUFFERED SIGNIFICANT PHYSICAL PERSONAL INJURIES DIRECTLY AND PROXIMATELY CAUSED BY THE AFOREMENTIONED IVC FILTER BECOMING IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATING [PT], AND/OR OTHERWISE BECOMING IRRETRIEVABLE." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
THIS ADDITIONAL INFORMATION RECEIVED 20MAR2018 AS FOLLOWS: PT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO CURRENT DEEP VEIN THROMBOSIS, ACUTE LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS WITH EXTENSIVE CLOT BURDEN. PT ALLEGES TILT, VENA CAVA PERFORATION, DEVICE UNABLE TO BE RETRIEVED, EMBEDMENT, LIFETIME ANTICOAGULATION POST IMPLANT. PT FURTHER ALLEGES PAIN, ANXIETY. ATTEMPTED FILTER RETRIEVAL (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395737 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Life Threatening |