COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2014-00032
- Event Type
- Death
- Date Received
- July 18, 2014
- Date of Event
- June 29, 2014
- Report Date
- February 25, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K090140
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4). CATALOG NUMBER: UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS CELECT FILTER SUMMARY OF INVESTIGATIONAL FINDING OF 05 JAN 2016: NO IMAGING IS PROVIDED AND PATIENT'S MEDICAL RECORDS ARE UNKNOWN AT THIS TIME. THEREFORE, IT IS NOT POSSIBLE TO COMMENT ON ADDITIONAL INFORMATION PROVIDED. AS TO REPORTED MIGRATION, IT IS NOT REPORTED IF DIAGNOSTIC IMAGING AFTER FILTER RELEASE VERIFIED CORRECT FILTER POSITION. 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. INVESTIGATION OF 11.JUL.2014 IS STILL VALID AND REMAINS UNCHANGED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATIONAL FINDING OF 11 JUL 2014: RPN AND LOT NUMBER WERE NOT PROVIDED, WHY DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, NOTHING INDICATES THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO DEVICE OR IMAGING FROM PROCEDURE HAVE BEEN AVAILABLE. IMAGE OF RETRIEVED FILTER CONFIRMS THAT BLOOD CLOT WAS CAPTURED INSIDE THE FILTER. POSSIBLE THAT THIS BLOOD CLOT INFLUENCED ON FILTER MIGRATION. SIMILAR EVENTS HAVE ALSO BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. THE EXACT ROOT CAUSE FOR THE FILTER MIGRATION CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.
(B)(4). INVESTIGATION, BASED ON THE NEWLY PROVIDED LOT NUMBER, IS STILL IN PROGRESS. SUMMARY OF INVESTIGATIONAL FINDING OF (B)(6) 2016: NO IMAGING IS PROVIDED AND PATIENT'S MEDICAL RECORDS ARE UNKNOWN AT THIS TIME. THEREFORE, IT IS NOT POSSIBLE TO COMMENT ON ADDITIONAL INFORMATION PROVIDED. AS TO REPORTED MIGRATION, IT IS NOT REPORTED IF DIAGNOSTIC IMAGING AFTER FILTER RELEASE VERIFIED CORRECT FILTER POSITION. 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. INVESTIGATION OF (B)(6) 2014 IS STILL VALID AND REMAINS UNCHANGED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATIONAL FINDING OF (B)(6) 2014: RPN AND LOT NUMBER WERE NOT PROVIDED, WHY DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, NOTHING INDICATES THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO DEVICE OR IMAGING FROM PROCEDURE HAVE BEEN AVAILABLE. IMAGE OF RETRIEVED FILTER CONFIRMS THAT BLOOD CLOT WAS CAPTURED INSIDE THE FILTER. POSSIBLE THAT THIS BLOOD CLOT INFLUENCED ON FILTER MIGRATION. SIMILAR EVENTS HAVE ALSO BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. THE EXACT ROOT CAUSE FOR THE FILTER MIGRATION CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.
(B)(4). SUMMARY OF INVESTIGATIONAL FINDING OF 23MAR2016: HOWEVER, INVESTIGATION DID NOT REVEAL ANY EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. PREVIOUS INVESTIGATION IS STILL VALID AND REMAINS UNCHANGED. SUMMARY OF INVESTIGATIONAL FINDING OF 05JAN2016: NO IMAGING IS PROVIDED AND PATIENT'S MEDICAL RECORDS ARE UNKNOWN AT THIS TIME. THEREFORE, IT IS NOT POSSIBLE TO COMMENT ON ADDITIONAL INFORMATION PROVIDED. AS TO REPORTED MIGRATION, IT IS NOT REPORTED IF DIAGNOSTIC IMAGING AFTER FILTER RELEASE VERIFIED CORRECT FILTER POSITION. 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. INVESTIGATION OF 11.JUL.2014 IS STILL VALID AND REMAINS UNCHANGED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATIONAL FINDING OF 11JUL2014: RPN AND LOT NUMBER WERE NOT PROVIDED, WHY DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, NOTHING INDICATES THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO DEVICE OR IMAGING FROM PROCEDURE HAVE BEEN AVAILABLE. IMAGE OF RETRIEVED FILTER CONFIRMS THAT BLOOD CLOT WAS CAPTURED INSIDE THE FILTER. POSSIBLE THAT THIS BLOOD CLOT INFLUENCED ON FILTER MIGRATION. SIMILAR EVENTS HAVE ALSO BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. THE EXACT ROOT CAUSE FOR THE FILTER MIGRATION CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.
(B)(4). CATALOG#: UNK AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS CELECT FILTER. RPN AND LOT NUMBER WERE NOT PROVIDED, WHY DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, NOTHING INDICATES THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO DEVICE OR IMAGING FROM PROCEDURE HAVE BEEN AVAILABLE. IMAGE OF RETRIEVED FILTER CONFIRMS THAT BLOOD CLOT WAS CAPTURED INSIDE THE FILTER. POSSIBLE THAT THIS BLOOD CLOT INFLUENCED ON FILTER MIGRATION. SIMILAR EVENTS HAVE ALSO BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. THE EXACT ROOT CAUSE FOR THE FILTER MIGRATION CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.
(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, PE, OCCLUSION, MIGRATION, CARDIAC PERFORATION, DIFF TO RETRIEVE-OPEN, ORGAN FAILURE, DEATH'. 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. 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. WITH ALL FILTERS, THERE IS SOME RISK OF FURTHER PULMONARY EMBOLISM. 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 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. IVC THROMBOTIC OCCLUSION AS AN OUTCOME FOR COOK IVC FILTERS IS ADDRESSED IN THE PUBLISHED SCIENTIFIC LITERATURE. IVC THROMBOTIC OCCLUSION IS DEFINED AS THE PRESENCE OF AN OCCLUDING THROMBUS IN THE IVC AFTER FILTER INSERTION AND DOCUMENTED BY ULTRASOUND (US), CT, MR IMAGING OR VENOGRAPHY; THIS MAY BE SYMPTOMATIC OR ASYMPTOMATIC. UNKNOWN IF THE REPORTED ORGAN FAILURE IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. 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.
(B)(4). CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: SERIOUS INJURY TO DEATH. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.
(B)(4). THE PATIENT INVOLVED WAS REPORTED TO BE DECEASED. DATE OF DEATH REPORTED TO BE (B)(6) 2014. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.
(B)(4). INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED, HOWEVER INVESTIGATION DATED (B)(6) 2018 IS STILL DEEMED VALID. 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE, OR UNCHANGED.
DESCRIPTION ACCORDING TO COMPLAINANT: THE PATIENT PRESENTED WITH A MALPOSITIONED FILTER IN THE LEFT VENTRICLE, 10 DAYS POST IMPLANT. ON EXAM, THE STAFF REPORTED THE PATIENTS IVC MEASURED TWICE WHAT IT DID DURING THE INITIAL PLACEMENT PROCEDURE. RETRIEVAL WAS UNSUCCESSFUL PERCUTANEOUSLY. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND AN OPEN PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE. ONCE REMOVED, THE DEVICE WAS FOUND TO BE ENCAPSULATED BY A HUGE CLOT BURDEN, IN AND AROUND THE FILTER. PATIENT OUTCOME: (B)(6) 2014 ACCORDING TO PHYSICIAN THE PATIENT WAS NOT DOING WELL AND WAS NOT REACTING TO NORMAL STIMULI. ADDITIONAL INFORMATION REQUESTED BUT NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED VIA LAWSUIT ON 23 DEC 2015: PATIENT PASSED AWAY, ALLEGEDLY BECAUSE, AT LEAST IN PART, "THE IVC FILTER HAD MIGRATED" AND "DAMAGED THE RIGHT VENTRICLE, RIGHT ATRIUM AND TRICUSPID VALVES," WHICH ALLEGEDLY REQUIRED "OPEN CHEST CARDIAC SURGERY" ON (B)(6) 2014, FROM WHICH PATIENT "BECAME SEPTIC... AD DEVELOPED MULTI-ORGAN FAILURE..." ACCORDING TO THE COMPLAINT, THE (B)(6) CORONER "DETERMINED THAT THE IMMEDIATE CAUSE OF DEATH TO BE COMPLICATIONS OF GREENFIELD FILTER PLACEMENT."
DESCRIPTION ACCORDING TO COMPLAINANT: THE PATIENT PRESENTED WITH A MALPOSITIONED FILTER IN THE LEFT VENTRICLE, 10 DAYS POST IMPLANT. ON EXAM, THE STAFF REPORTED THE PATIENTS IVC MEASURED TWICE WHAT IT DID DURING THE INITIAL PLACEMENT PROCEDURE. RETRIEVAL WAS UNSUCCESSFUL PERCUTANEOUSLY. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND AN OPEN PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE. ONCE REMOVED, THE DEVICE WAS FOUND TO BE ENCAPSULATED BY A HUGE CLOT BURDEN, IN AND AROUND THE FILTER. PATIENT OUTCOME: (B)(6) 2014 ACCORDING TO PHYSICIAN THE PATIENT WAS NOT DOING WELL AND WAS NOT REACTING TO NORMAL STIMULI. ADDITIONAL INFORMATION REQUESTED BUT NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED VIA LAWSUIT ON (B)(6) 2015: PATIENT PASSED AWAY, ALLEGEDLY BECAUSE, AT LEAST IN PART, "THE IVC FILTER HAD MIGRATED" AND "DAMAGED THE RIGHT VENTRICLE, RIGHT ATRIUM AND TRICUSPID VALVES," WHICH ALLEGEDLY REQUIRED "OPEN CHEST CARDIAC SURGERY" ON (B)(6) 2014, FROM WHICH PATIENT "BECAME SEPTIC... AND DEVELOPED MULTI-ORGAN FAILURE..." ACCORDING TO THE COMPLAINT, THE BUTLER COUNTY CORONER "DETERMINED THAT THE IMMEDIATE CAUSE OF DEATH TO BE COMPLICATIONS OF GREENFIELD FILTER PLACEMENT."
DESCRIPTION ACCORDING TO COMPLAINANT: THE PATIENT PRESENTED WITH A MALPOSITIONED FILTER IN THE LEFT VENTRICLE, 10 DAYS POST IMPLANT. ON EXAM, THE STAFF REPORTED THE PATIENTS IVC MEASURED TWICE WHAT IT DID DURING THE INITIAL PLACEMENT PROCEDURE. RETRIEVAL WAS UNSUCCESSFUL PERCUTANEOUSLY. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND AN OPEN PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE. ONCE REMOVED, THE DEVICE WAS FOUND TO BE ENCAPSULATED BY A HUGE CLOT BURDEN, IN AND AROUND THE FILTER. PATIENT OUTCOME: ON (B)(6) 2014, ACCORDING TO PHYSICIAN, THE PATIENT WAS NOT DOING WELL AND WAS NOT REACTING TO NORMAL STIMULI. ADDITIONAL INFORMATION REQUESTED BUT NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED VIA LAWSUIT ON 23DEC2015: PATIENT PASSED AWAY, ALLEGEDLY BECAUSE, AT LEAST IN PART, ¿THE IVC FILTER HAD MIGRATED¿ AND ¿DAMAGED THE RIGHT VENTRICLE, RIGHT ATRIUM AND TRICUSPID VALVES,¿ WHICH ALLEGEDLY REQUIRED ¿OPEN CHEST CARDIAC SURGERY¿ ON (B)(6) 2014, FROM WHICH PATIENT "BECAME SEPTIC¿AND DEVELOPED MULTI-ORGAN FAILURE¿.¿ ACCORDING TO THE COMPLAINT, THE BUTLER COUNTY CORONER ¿DETERMINED THAT THE IMMEDIATE CAUSE OF DEATH TO BE COMPLICATIONS OF GREENFIELD FILTER PLACEMENT.¿
DESCRIPTION ACCORDING TO COMPLAINANT: THE PATIENT PRESENTED WITH A MALPOSITIONED FILTER IN THE LEFT VENTRICLE, 10 DAYS POST IMPLANT. ON EXAM, THE STAFF REPORTED THE PATIENTS IVC MEASURED TWICE WHAT IT DID DURING THE INITIAL PLACEMENT PROCEDURE. RETRIEVAL WAS UNSUCCESSFUL PERCUTANEOUSLY. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND AN OPEN PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE. ONCE REMOVED, THE DEVICE WAS FOUND TO BE ENCAPSULATED BY A HUGE CLOT BURDEN, IN AND AROUND THE FILTER. PATIENT OUTCOME: (B)(6) 2014 ACCORDING TO PHYSICIAN THE PATIENT WAS NOT DOING WELL AND WAS NOT REACTING TO NORMAL STIMULI. ADDITIONAL INFORMATION REQUESTED BUT NOT PROVIDED.
THIS ADDITIONAL INFORMATION RECEIVED ON 25/JAN/2017 AS FOLLOWS: PATIENT RECEIVED AN IMPLANT ON (B)(6) 2014 VIA THE COMMON FEMORAL VEIN DUE TO PARTIALLY-OCCLUDING LEFT POPLITEAL VEIN DEEP VEIN THROMBOSIS, GI BLEED, CONTRAINDICATION TO ANTICOAGULATION. THE PATIENT PRESENTED WITH A MALPOSITIONED FILTER IN THE LEFT VENTRICLE, 10 DAYS POST IMPLANT. ON EXAM, THE STAFF REPORTED THE PATIENTS IVC MEASURED TWICE WHAT IT DID DURING THE INITIAL PLACEMENT PROCEDURE. RETRIEVAL WAS UNSUCCESSFUL PERCUTANEOUSLY. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND AN OPEN PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE. ONCE REMOVED, THE DEVICE WAS FOUND TO BE ENCAPSULATED BY A HUGE CLOT BURDEN, IN AND AROUND THE FILTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422537 | COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Death| L |