COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2019-00685
- Event Type
- Injury
- Date Received
- June 3, 2019
- Report Date
- October 3, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
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 CELECT FILTER. E3) OCCUPATION: NON-HEALTHCARE PROFESSIONAL. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. 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. 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.
THE INVESTIGATION WAS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: FILTER TILT, VENA CAVA (VC) PERFORATION, ORGAN PERFORATION, DEEP VEIN THROMBOSIS (DVT), AND POST-THROMBOTIC SYNDROME. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. VENA CAVA WALL PENETRATION/PERFORATION HAS BEEN REPORTED AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. IVC OCCLUSION/ THROMBOSIS, NEW DVT, IVC STENOSIS AS A REPORTED COMPLICATION, IS A KNOWN RISK IN RELATION TO FILTER IMPLANT AND IS WELL DOCUMENTED IN THE CLINICAL LITERATURE AND IN CLINICAL PRACTICE GUIDELINES. THIS IS SUPPORTED BY THE CLINICAL EVIDENCE REPORT ESTABLISHED TO ASSESS AVAILABLE CLINICAL DATA TO IDENTIFY AND EVALUATE THE CLINICAL SAFETY AND PERFORMANCE OF THE COOK VENA CAVA FILTERS. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: VENA CAVA OCCLUSION OR THROMBOSIS, VENA CAVA STENOSIS, DEEP VEIN THROMBOSIS. FILTER TILT HAS BEEN REPORTED. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER); AND (OR) A FAILED RETRIEVAL ATTEMPT. EXCESSIVE FILTER TILT MAY CONTRIBUTE TO DIFFICULT OR FAILED RETRIEVAL; VENA CAVA WALL PENETRATION/PERFORATION; AND (OR) RESULT IN LOSS OF FILTER EFFICIENCY. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: UNACCEPTABLE FILTER TILT. UNKNOWN IF THE REPORTED POST-THROMBOTIC SYNDROME IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. NO RELEVANT NOTES ON WO (WORK ORDER) FOR NEITHER DEVICE LOT, NOR FILTER LOT(S). NO OTHER COMPLAINTS ON LOTS. 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. 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 BECOMES 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.
THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE 3 SYSTEM CONTROLLER IS (B)(4).
'IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2015". IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON 18JAN2015 VIA THE LEFT COMMON FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT) INVOLVING THE ENTIRE RIGHT LOWER EXTREMITY. PATIENT IS ALLEGING FILTER TILT, VENA CAVA PERFORATION, ORGAN PERFORATION, DVT, AND POST-THROMBOTIC SYNDROME. (B)(6) 2015 OPERATIVE PROCEDURE REPORT. "DVT THROMBECTOMY OF THE PATIENT'S RIGHT POPLITEAL VEIN, SFV, COMMON FEMORAL VEIN, EXTERNAL AND COMMON ILIAC VEINS AS WELL AS PROXIMAL IVC USING THE TRELLIS DVT THROMBECTOMY DEVICE. ANGIOPLASTY OF THE PATIENT'S COMMON ILIAC VEIN AND THE PROXIMAL IVC WITH AN 8 X 40 AND THEN A 10 X 40 MM BALLOON, REDUCING A 90% STENOSIS DOWN TO ABOUT 20. ANGIOPLASTY OF THE COMMON FEMORAL VEIN ON THE RIGHT SIDE WITH AN 8 X 40 AND THEN A 10 X 40 MM BALLOON, REDUCING A 70% STENOSIS DOWN TO 10. OCCLUSIVE DVT INVOLVING THE ILIOFEMORAL VEIN POST L5-S1 LAMINECTOMY. LEG CONTINUED TO HAVE PERSISTENT TENSE EDEMA. WE THEN ADVANCED A SUPERCOIL WIRE AND PARKED IT IN THE IVC BEYOND THE IVC FILTER AND EXCHANGED THE ANGLED TAPER CATHETER WITH A TRELLIS CATHETER AND PERFORMED SEGMENTAL THROMBECTOMY WITH THE TRELLIS CATHETER USING A TOTAL OF 15 MG OF TPA." OVERALL IMPRESSION: "STATUS POST DEEP VENOUS THROMBOSIS THROMBECTOMY AND ANGIOPLASTY OF THE COMMON FEMORAL VEIN AS WELL AS THE COMMON ILIAC VEIN AND THE PROXIMAL INFERIOR VENA CAVA SUCCESSFULLY." (B)(6) 2018 CT ABDOMEN W/O CONTRAST. FINDINGS: "THE INFRARENAL INFERIOR VENA CAVA FILTER IS TILTED ANTERIORLY WITH THE APEX ABUTTING THE ANTERIOR WALL OF THE IVC. THE FILTER TINES EXIT THE IVC, WITH ONE OF THE TINES POSSIBLY PROTRUDING INTO THE WALL OF THE AORTA." IMPRESSION: THE IVC FILTER APPEARS ANTERIORLY TILTED WITH THE TINES EXITING THE IVC AS DESCRIBED."
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455867 | COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E3267424 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |