COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
Report
- Report Number
- 3002808486-2017-02051
- Event Type
- Injury
- Date Received
- October 20, 2017
- Report Date
- August 6, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K073374
- Adverse Event
- Yes
- Product Problem
- 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). ADDITIONAL INFORMATION: (EXPIRATION DATE). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: (B)(4). 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). MANUFACTURER REF# (B)(4). D4) CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT 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 THE 510(K) COULD BE EITHER K061815, K073374, K090140 OR K112119. (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 MFR SITE: NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). 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 'PE, DVT, PAIN, RETROPERITONEAL HEMATOMA, ANXIETY, STRESS'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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 RETROPERITONEAL HEMATOMA, ANXIETY, STRESS 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). MFR SITE: NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). ADDITIONAL INFORMATION: 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 'CELECT, PE, DVT, PAIN, RETROPERITONEAL HEMATOMA, ANXIETY, STRESS'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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 RETROPERITONEAL HEMATOMA, ANXIETY, STRESS 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. CELECT FILTER ARE 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.
NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.
DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT 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.
NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.
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 ¿CELECT 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.
EXEMPTION NUMBER E2016032. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
THIS ADDITIONAL INFORMATION RECEIVED ON 13FEB2018 AS FOLLOWS: ¿[PT] ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 DUE TO PULMONARY EMBOLISM, PROPHYLAXIS-PENDING SURGERY. [PT] IS ALLEGING PULMONARY EMBOLISM, DEEP VEIN THROMBOSIS, PAIN POST-IMPLANT, RETROPERITONEAL HEMATOMA. [PT] FURTHER ALLEGES ANXIETY/STRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 744669 | COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E2878212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |