COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2017-00443
- Event Type
- Death
- Date Received
- February 10, 2017
- Report Date
- May 16, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K121629
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, 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). MANUFACTURER REF# (B)(4). H11) CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: B1: PRODUCT PROBLEM TO ADVERSE EVENT AND PRODUCT PROBLEM. H1: MALFUNCTION TO SERIOUS INJURY. 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 "TILT, FRACTURE AND PAIN". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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. 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 FILTER FRAGMENT EMBOLIZED INTO THE HEART OR LUNG MAY BE SAFELY RETRIEVED. 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.
MANUFACTURER REF# (B)(4). EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION. (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. 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 OR 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.
ADDITIONAL INFORMATION RECEIVED 3/10/2017: THE PLAINTIFF ALLEGEDLY RECEIVED DEVICE IMPLANT VIA THE LEFT COMMON FEMORAL VEIN ON (B)(6) 2015 DUE TO RIGHT LOWER EXTREMITY DEEP VEIN THROMBOSIS. PLAINTIFF ALLEGES DEVICE TILT AND FRACTURE, SEVERE NECK PAIN, SEVERE INNER THIGH PAIN, CHEST PAIN AND SWELLING OF THE RIGHT LEG AND RIGHT SIDE OF THE NECK. IT IS ALLEGED THAT THE DEVICE WAS REMOVED VIA THE RIGHT INTERNAL JUGULAR VEIN ON (B)(6) 2015.
(B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.
ADDITIONAL INFORMATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: LEG PAIN, NECK PAIN, CHEST PAIN. UNKNOWN IF THE REPORTED LEG PAIN, NECK PAIN, AND CHEST PAIN ARE 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. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. EXEMPTION NUMBER E2016032. WILLIAM COOK (B)(4) (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). (B)(4).
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A CELECT FILTER ON (B)(6) 2015". PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
DATED (B)(6) 2015, FOLLOW UP VENOGRAPHY OF THE RIGHT LOWER EXTREMITY, REPORTS, "THE FILTER WAS TILTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105673 | COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| O |