GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2017-01743
- Event Type
- Death
- Date Received
- September 4, 2017
- Report Date
- April 23, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K090140
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SINCE CATALOG# IS UNKNOWN 510(K) COULD BE EITHER K090140, K112119 OR K121057. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. ADDITIONAL INFORMATION: INVESTIGATION: 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, CAVAL AND FILTER THROMBOSIS, RENAL FAILURE, DEATH, ANXIETY'. 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. 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 RENAL FAILURE, ANXIETY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. NO RELEVANT NOTES FOUND IN DEVICE WORK ORDER. NO OTHER COMPLAINTS FOUND IN DEVICE LOT. 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. ADDITIONAL INFORMATION: INVESTIGATION - 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 (DEATH), CAVAL + FILTER THROMBOSIS, RENAL FAILURE, ANXIETY, DVT -'. 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. 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 RENAL FAILURE, ANXIETY, IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. UNKNOWN IF THE REPORTED PERIPHERAL VEIN THROMBOSIS IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE 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. 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). CORRECTED DATA: B1,B2 H1. (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 300558011. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2012". 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 ON 15MAR2018 AS FOLLOWS: PT ALLEGES POST IMPLANT DEEP VEIN THROMBOSIS AND POST IMPLANT PULMONARY EMBOLISM.
THIS ADDITIONAL INFORMATION RECEIVED ON 01FEB2018 AS FOLLOWS: PT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT INTERNAL JUGULAR VEIN THE DUE TO DEEP VEIN THROMBOSIS. PT IS ALLEGING CAVAL THROMBOSIS, FILTER THROMBOSIS/EMBOLISM, THROMBOTIC EVENT, DEVICE MALFUNCTION IN-PATIENT HOSPITAL TREATMENT, RENAL FAILURE, DEATH. PT FURTHER ALLEGES ANXIETY. PT IS REPORTED HAVING EXPIRED (B)(6) 2017, WITHOUT FURTHER DETAILS.
EXEMPTION NUMBER E2016032. (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 ¿GUNTHER TULIP FILTER IMPLANTED". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620711 | GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |