COOK CELECT FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2015-00121
- Event Type
- Death
- Date Received
- October 22, 2015
- Date of Event
- September 22, 2013
- Report Date
- June 29, 2017
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K073374
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS COOK CELECT FILTER. AS CATALOG # IS UNKNOWN IT COULD BE EITHER K061815, K073374 OR K090140. SUMMARY OF INVESTIGATIONAL FINDINGS: NO IMAGING IS PROVIDED AND IMPLANT DATE AND PATIENT MEDICAL HISTORY IS UNKNOWN AT THIS TIME. WITHOUT IMAGING IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE ALLEGED FILTER FRACTURE. ALSO IT IS NOT POSSIBLE TO COMMENT ON THE ALLEGED WORSENING PAIN AND DISCOMFORT AS FRAGMENTS OF THE FILTER "BECAME EMBEDDED IN TISSUE THROUGHOUT HIS BODY". HOWEVER, FRACTURE OF THE WIRE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. LOT# AND RPN ARE UNKNOWN; HOWEVER THE CELECT FILTER IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. 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. NO EVIDENCE TO SUGGEST DEVICE FAILURE BASED ON INFORMATION PROVIDED. RELEVANT INDIVIDUALS INFORMED AND COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.
(B)(4). CATALOG # : IGTCFS-65-FEM-CELECT-PERM. UNKNOWN, BUT REFERRED TO AS (B)(6) 2009. SUMMARY OF INVESTIGATIONAL FINDINGS: ON (B)(6) 2015: COMPLAINT RE-OPENED SINCE LOT# WAS PROVIDED. INVESTIGATION OF DOCUMENTATION FOUND NO EVIDENCE TO SUGGEST PRODUCT IN QUESTION WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. HOWEVER, SINCE LOT# IS THE ONLY ADDITIONAL INFORMATION PROVIDED THE INVESTIGATION OF (B)(6) 2015 IS STILL VALID AND REMAINS UNCHANGED. ON 21.OCT.2015: NO IMAGING IS PROVIDED AND IMPLANT DATE AND PATIENT MEDICAL HISTORY IS UNKNOWN AT THIS TIME. WITHOUT IMAGING IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE ALLEGED FILTER FRACTURE. ALSO IT IS NOT POSSIBLE TO COMMENT ON THE ALLEGED WORSENING PAIN AND DISCOMFORT AS FRAGMENTS OF THE FILTER "BECAME EMBEDDED IN TISSUE THROUGHOUT HIS BODY". HOWEVER, FRACTURE OF THE WIRE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. LOT# AND RPN ARE UNKNOWN; HOWEVER THE CELECT FILTER IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. 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. NO EVIDENCE TO SUGGEST DEVICE FAILURE BASED ON INFORMATION PROVIDED. RELEVANT INDIVIDUALS INFORMED AND COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.
(B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS COOK CELECT FILTER. IMPLANTED DATE: UNKNOWN, BUT REFERED TO AS (B)(6) 2009. PMA/510(K): AS CATALOG # IS UNKNOWN IT COULD BE EITHER (B)(4), (B)(4) OR (B)(4). INVESTIGATION IS STILL IN PROGRESS .
(B)(4). WILLIAM COOK EUROPE IS NOT ASSUMING RESPONSIBILITY FOR PATIENT DEATH AS IT IS UNCLEAR THE REASON FOR DEATH. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.
(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 'CELECT, ORGAN + VC PERFORATION, MIGRATION, UNABLE TO BE RETRIEVED, FRACTURE, PAIN: PT EXPIRED'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. UNKNOWN IF THE REPORTED PATIENT DEATH IS RELATED TO THE FILTER. MANIPULATION IN THE AREA OF THE FILTER IMPLANT MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. 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 FRACTURE IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. FRACTURE OF A FILTER LEG CAN BE DUE TO REPETITIVE MOTION ON A FILTER LEG IN AN UNUSUAL STRESSED POSITION. AMONG OTHER CAUSES, FILTER FRACTURE MAY BE ASSOCIATED WITH A FILTER LEG PERFORATING THE IVC, A FILTER LEG BEING CAUGHT IN A SIDE BRANCH (E.G. RENAL VEIN), 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. IT HAS BEEN REPORTED THAT RETRIEVAL OF A FRACTURED FILTER OR FILTER FRAGMENTS USING ENDOVASCULAR TECHNIQUES IS POSSIBLE. FRACTURE OF THE WIRE IS A KNOWN RISK IN RELATION TO AN IMPLANTED FILTER AND REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. IT IS KNOWN FROM THE PUBLISHED SCIENTIFIC LITERATURE THAT A FILTER FRAGMENT EMBOLIZED INTO THE HEART OR LUNG MAY BE SAFELY RETRIEVED. 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 OF EVENT ACCORDING TO COMPLAINANT: IT IS ALLEGED THAT "[PT] WAS ADMITTED TO (B)(6) FOR SURGERY FOLLOWING A TRAUMATIC INJURY. THE FILTER WAS POSITIONED AND DEPLOYED WITHOUT COMPLICATIONS". SUBSEQUENTLY, "HEALTH CARE PROVIDERS DETERMINED AND REPORTED TO [PT] THAT THE COOK CELECT FILTER HAD FRACTURED AND THE FRAGMENTS HAD MIGRATED". HE ALLEGEDLY EXPERIENCED WORSENING PAIN AND DISCOMFORT AS FRAGMENTS OF THE FILTER "BECAME EMBEDDED IN TISSUE THROUGHOUT HIS BODY". DECEDENT ALLEGEDLY TOOK HIS OWN LIFE ON (B)(6) 2013 AFTER BEING "UNABLE TO FIND RELIEF FROM THE CONSTANT PAIN". PATIENT OUTCOME: IT IS ALLEGED THAT "[PT] ALLEGEDLY EXPERIENCED WORSENING PAIN AND DISCOMFORT AS FRAGMENTS OF THE FILTER "BECAME EMBEDDED IN TISSUE THROUGHOUT HIS BODY". DECEDENT ALLEGEDLY TOOK HIS OWN LIFE ON (B)(6) 2013 AFTER BEING "UNABLE TO FIND RELIEF FROM THE CONSTANT PAIN"
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: IT IS ALLEGED THAT "[PT] WAS ADMITTED TO (B)(6) FOR SURGERY FOLLOWING A TRAUMATIC INJURY. THE FILTER WAS POSITIONED AND DEPLOYED WITHOUT COMPLICATIONS". SUBSEQUENTLY, "HEALTH CARE PROVIDERS DETERMINED AND REPORTED TO [PT] THAT THE COOK CELECT FILTER HAD FRACTURED AND THE FRAGMENTS HAD MIGRATED". HE ALLEGEDLY EXPERIENCED WORSENING PAIN AND DISCOMFORT AS FRAGMENTS OF THE FILTER "BECAME EMBEDDED IN TISSUE THROUGHOUT HIS BODY". DECEDENT ALLEGEDLY TOOK HIS OWN LIFE ON (B)(6) 2013 AFTER BEING "[U]NABLE TO FIND RELIEF FROM THE CONSTANT PAIN". PATIENT OUTCOME: IT IS ALLEGED THAT "[PT] ALLEGEDLY EXPERIENCED WORSENING PAIN AND DISCOMFORT AS FRAGMENTS OF THE FILTER "BECAME EMBEDDED IN TISSUE THROUGHOUT HIS BODY". DECEDENT ALLEGEDLY TOOK HIS OWN LIFE ON 9/22/13 AFTER BEING "[U]NABLE TO FIND RELIEF FROM THE CONSTANT PAIN"
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: IT IS ALLEGED THAT "[PT] WAS ADMITTED TO (B)(6) FOR SURGERY FOLLOWING A TRAUMATIC INJURY. THE FILTER WAS POSITIONED AND DEPLOYED WITHOUT COMPLICATIONS". SUBSEQUENTLY, "HEALTH CARE PROVIDERS DETERMINED AND REPORTED TO [PT] THAT THE COOK CELECT FILTER HAD FRACTURED AND THE FRAGMENTS HAD MIGRATED". HE ALLEGEDLY EXPERIENCED WORSENING PAIN AND DISCOMFORT AS FRAGMENTS OF THE FILTER "BECAME EMBEDDED IN TISSUE THROUGHOUT HIS BODY". DECEDENT ALLEGEDLY TOOK HIS OWN LIFE ON (B)(6) 2013 AFTER BEING "[U]NABLE TO FIND RELIEF FROM THE CONSTANT PAIN". PATIENT OUTCOME: IT IS ALLEGED THAT "[PT] ALLEGEDLY EXPERIENCED WORSENING PAIN AND DISCOMFORT AS FRAGMENTS OF THE FILTER "BECAME EMBEDDED IN TISSUE THROUGHOUT HIS BODY". DECEDENT ALLEGEDLY TOOK HIS OWN LIFE ON (B)(6) 2013 AFTER BEING "[U]NABLE TO FIND RELIEF FROM THE CONSTANT PAIN".
THIS ADDITIONAL INFORMATION WAS RECEIVED ON 12/04/2015 AS FOLLOWS: THE PATIENT ALLEGEDLY RECEIVED THE FILTER IMPLANT ON (B)(6) 2009 AS PE PROPHYLAXIS FOLLOWING A MOTOR VEHICLE ACCIDENT IN WHICH THE PATIENT SUSTAINED BRAIN INJURY AND LOSS OF LEG. DECEDENT TOOK HIS OWN LIFE ON (B)(6)2013 AFTER BEING "[U]NABLE TO FIND RELIEF FROM THE CONSTANT PAIN". THE ESTATE ALLEGES ORGAN AND VENA CAVA PERFORATION, MIGRATION, DEVICE UNABLE TO BE RETRIEVED, CHRONIC PAIN, AND INABILITY TO SLEEP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 697853 | COOK CELECT FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Death |