GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 1820334-2016-00529
- Event Type
- Injury
- Date Received
- June 15, 2016
- Report Date
- May 16, 2018
- Manufacturer
- COOK INC
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
INVESTIGATION: 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 'TULIP, PE, TILT, FRACTURE (IN SITU), ORGAN PERFORATION, DIFFICULT RETRIEVAL (EMB'D), 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. 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. 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. 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. UNKNOWN IF THE REPORTED PAIN/DISCOMFORT IS DIRECTLY RELATED TO THE FILTER. UNKNOWN IF THE REPORTED ANXIETY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. PRODUCT 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. 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE, OR UNCHANGED. INVESTIGATION: 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 'TULIP, PE, TILT, FRACTURE (IN SITU), ORGAN PERFORATION, DIFFICULT RETRIEVAL (EMB'D), 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. 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. 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. 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. UNKNOWN IF THE REPORTED PAIN/DISCOMFORT IS DIRECTLY RELATED TO THE FILTER. UNKNOWN IF THE REPORTED ANXIETY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. PRODUCT 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. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PATIENT CODE: NO KNOWN CONSEQUENCE REPORTED. DEVICE CODE: NO KNOWN DEVICE PROBLEM REPORTED. THE EVENT IS CURRENTLY UNDER INVESTIGATION.
(B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
THE PATIENT RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2007 AT AN UNNAMED HOSPITAL IN (B)(6). IT IS ALLEGED THAT PATIENT WAS INJURED (IVC FILTER BECOMING IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATION, AND/OR OTHERWISE BECOMING IRRETRIEVABLE) ON OR AROUND (B)(6) 2015 WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED. (B)(4). EVALUATION - NO INFORMATION REGARDING THE EVENT. THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. PATIENTS MEDICAL RECORDS ARE UNKNOWN AND NO IMAGING IS PROVIDED. THEREFORE, IT IS IMPOSSIBLE TO COMMENT ON THE ALLEGED INJURIES 9 YEARS AFTER PLACEMENT. WE HAVE INVESTIGATED BASED ON THE INFORMATION RECEIVED TO DATE, AND ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED FOR INVESTIGATION. 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. IFU, CONTRAINDICATIONS: MEGACAVA (DIAMETER OF THE IVC > 30 MM). IT IS COOK¿S EXPERIENCE THAT FRACTURE OF FILTER LEGS IS DUE TO UNIDIRECTIONAL BENDING FATIGUE. THE TYPE OF FATIGUE IS A HIGH CYCLE FATIGUE WHERE CYCLIC LOW STRESSES WITH LOW STRESS CONCENTRATIONS WERE APPLIED TO THE FILTER LEG. THE BENDING MOMENT OF THE FILTER LEG MAY BE INTRODUCED BY DIFFERENT SCENARIOS THAT IN SOME INSTANCES WILL CHANGE THE FILTER¿S ORIGINAL CONFIGURATION, E.G. BY PERFORATION OF THE IVC WALL, OR BY CAUGHT IN A BODY STRUCTURE (E.G. RENAL VEIN). 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. 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. 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. CATALOG AND LOT# ARE UNKNOWN, BUT THE TULIP FILTER MANUFACTURED/INSPECTED ACCORDING TO SPECIFICATIONS. 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. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE REOPENED FOR FURTHER INVESTIGATION.
THE PATIENT RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2007 AT AN UNNAMED HOSPITAL IN (B)(6) . PLAINTIFF HAS NOT NAMED AN IMPLANTING PHYSICIAN. IT IS ALLEGED THAT PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
THIS ADDITIONAL INFORMATION RECEIVED ON 19APR2018 AS FOLLOWS: PT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2007 VIA THE RIGHT FEMORAL VEIN DUE TO A HISTORY OF PULMONARY EMBOLUS AND PROPHYLAXIS FOR CHOLECYSTECTOMY,APPENDECTOMY. PT ALLEGES TILT, FRACTURE, ORGAN PERFORATION (LEFT RENAL VEIN, PELVIC VEINS, SPINE), EMBEDMENT, STRUT REMAINING NEAR RIGHT ILIAC CREST, POST IMPLANT PAIN (CHEST, LUNG, PELVIC). PT FURTHER ALLEGES ANXIETY, POST IMPLANT PULMONARY EMBOLISM. ALLEGED FILTER RETRIEVAL PERFORMED ON (B)(6) 2015, WITH STRUT REMAINING NEAR RIGHT ILIAC CREST. RETRIEVAL PERFORMED DUE TO EMBEDMENT.
THE PATIENT RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2007 AT AN UNNAMED HOSPITAL IN (B)(6). IT IS ALLEGED THAT PATIENT WAS INJURED (IVC FILTER BECOMING IMBEDDED, TILTING, MIGRATING, FRACTURING, PERFORATING PLAINTIFF, AND/OR OTHERWISE BECOMING IRRETRIEVABLE) ON OR AROUND (B)(6) 2015 WITHOUT FURTHER EXPLANATION. PATIENT IS SEEKING PUNITIVE DAMAGES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380872 | GUNTHER TULIP FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| O |