GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 1820334-2016-00164
- Event Type
- Injury
- Date Received
- March 31, 2016
- Report Date
- February 24, 2020
- Manufacturer
- COOK INC
- Product Code
- DTK
- UDI-DI
- 10827002330167
- PMA / PMN Number
- K043509
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- ATTORNEY
Narratives
ADDITIONAL INFORMATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: SHORTNESS OF BREATH. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. UNKNOWN IF THE REPORTED SHORTNESS OF BREATH IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. (B)(4) DEVICES IN LOT. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED AGAINST THE LOT. THE ASSOCIATED WORK ORDER WAS REVIEWED. NO RELATED/RELEVANT NOTES WERE DOCUMENTED. THE DEVICE 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. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
PER A REPORT FROM COMPUTERIZED TOMOGRAPHY (CT): "AN IVC IS AGAIN IS NOTED, UNCHANGED IN POSITION COMPARED TO ON (B)(6) 2013. THE CEPHALAD END OF THE IVC FILTER IS APPROXIMATELY 3 CM BELOW THE RENAL VEIN INFLOW. LEGS OF THE IVC FILTER EXTEND OUTSIDE THE LUMEN CAUDALLY, BUT THIS IS UNCHANGED COMPARED TO PRIOR EXAM".
INITIAL MDR REPORT WAS SUBMITTED BY WILLIAM COOK EUROPE UNDER 3002808486-2016-00007 AS THE MANUFACTURER WAS NOT DETERMINED AT THE TIME. NEW LOT INFORMATION PROVIDED ON 17 FEBRUARY 2016 INDICATED THE DEVICE WAS MANUFACTURED BY COOK INC., 1820344-2016-00164. (B)(4). INVESTIGATION- NO INFORMATION REGARDING THE EVENT WAS PROVIDED TO ASSIST WITH THE INVESTIGATION. THE INVESTIGATION WAS BASED ON THE INFORMATION RECEIVED TO DATE, AND ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED FOR INVESTIGATION. IT IS IMPOSSIBLE TO COMMENT ON ALLEGED INJURIES NO EVIDENCE TO SUGGEST A DEVICE FAILURE. NO CONCLUSION COULD BE DRAWN.
THE EVENT IS CURRENTLY UNDER EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.
ADDITIONAL INFORMATION: 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 'VENA CAVA PERFORATION, SHORTNESS OF BREATH, DEVICE UNABLE TO RETRIEVE'. 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 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. 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.
VENA CAVA PERFORATION. SHORTNESS OF BREATH. DEVICE IS UNABLE TO BE RETRIEVED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.
(B)(4). ACCORDING TO DEVICE HISTORY RECORDS, BASED ON THE LOT NUMBER PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS OR THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G., THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA IN THE SITUATIONS DESCRIBED IN THE IFU. IT HAS NOT BEEN POSSIBLE TO FULLY INVESTIGATE OR EVALUATE THIS EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE.
WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MFR REPORT # 3002808486-2016-00007. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. MANUFACTURED DEVICE. AN UPDATED EMDR REPORT WAS SUBMITTED UNDER COOK INC. MFR REPORT # 1820344-2016-00164, FOLLOW UP # 1. THIS WAS IN REFERENCE TO WILLIAM COOK EUROPE MFR REPORT # 3002808486-2016-00007. COOK IS NOW SUBMITTING AN INITIAL REPORT TO CORRECT THIS ISSUE. EVALUATION- THE PRODUCT WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. NO INFORMATION REGARDING THE EVENT WAS PROVIDED. NO NOTES OF RELEVANCE FOUND IN THE DEVICE WORK ORDER, NOR ON THE FILTER LOT NUMBER. NO OTHER COMPLAINTS HAVE BEEN RECEIVED RELEVANT TO THIS LOT. IMPOSSIBLE TO COMMENT ON THE ALLEGED INJURIES. DEVICE MANUFACTURED/INSPECTED ACCORDING TO SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. NO EVIDENCE TO SUGGEST A DEVICE FAILURE. WE HAVE NOTIFIED APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE REOPENED FOR FURTHER INVESTIGATION.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2012 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 GUNTHER TULIP FILTER ON (B)(6) 2012 AT (B)(6) MEDICAL CENTER." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED. ADDITIONAL INFORMATION RECEIVED JANUARY 30, 2017: IT IS ALLEGED IN THE PENDING LAWSUIT THAT PT SUFFERS FROM VENA CAVA PERFORATION AND THE INABILITY TO RETRIEVE THE DEVICE.
THIS ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2016 AS FOLLOWS: THE PLAINTIFF ALLEGEDLY RECEIVED THE DEVICE IMPLANT ON (B)(6) 2012 VIA RIGHT COMMON FEMORAL DUE TO DVT. PLAINTIFF IS ALLEGING VENA CAVA PERFORATION, SHORTNESS OF BREATH, AND THE DEVICE IS UNABLE TO BE RETRIEVED.
IT IS ALLEGED THAT [PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2012. IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2017: IT IS ALLEGED IN THE PENDING LAWSUIT THAT PT SUFFERS FROM VENA CAVA PERFORATION AND THE INABILITY TO RETRIEVE THE DEVICE.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2012 AT THE (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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196207 | GUNTHER TULIP FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | NA | 10827002330167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Life Threatening| O |