COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2019-00087
- Event Type
- Injury
- Date Received
- January 17, 2019
- Report Date
- June 27, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION ¿ INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. 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. 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. 20 DEVICES IN LOT. NO RELEVANT NOTES ON WO FOR NEITHER DEVICE (IGTCFS-65-1-FEM-CELECT) LOT: E2593242, NOR FILTER (IGTF-30-CELECT) LOT:(E2590879 + E2590148). ONE OTHER COMPLAINT ((B)(4)) ON LOT. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO (B)(4) (DEVICE MI), (B)(4) (DEVICE QCI), (B)(4) (CELECT MI), (B)(4) (CELECT QCI). THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: TILT, VC PERFORATION . 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 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). NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) (B)(4). REGISTRATION NO.: (B)(4).
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(6) (IMPORTER). G1) NAME AND ADDRESS FOR IMPORTER SITE: (B)(6). 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.
PATIENT CODE: VESSELS, PERFORATION OF (2135), LISTED IN IFU. DEVICE CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (3191), LISTED IN IFU. EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE, OR UNCHANGED. 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). (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING ¿TILT, VC PERFORATION". 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. 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. 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 MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE RIGHT COMMON FEMORAL VEIN. CT 2, (B)(6) 2018: "ALL OF THE IVC STRUTS PROTRUDE THROUGH THE WALLS OF THE IVC CONSISTENT WITH GRADE 2 PERFORATIONS. THE IVC FILTER IS ALSO ANGLED AND THE TIP PROTRUDES THROUGH THE IVC FILTER AS WELL CONSISTENT WITH GRADE 2 PERFORATION.
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 DUE TO A HISTORY OF DEEP VEIN THROMBOSIS, PULMONARY EMBOLISM AND A LIFE LONG NEED FOR COUMADIN. PATIENT ALLEGES VENA CAVA PERFORATION. PER CT, (B)(6) 2018: "POSITIVE FOR CAVA PERFORATION. A TOTAL OF FOUR PRONGS HAVE PERFORATED IVC.5.89 DEGREE OF TILT OF FILTER RIGHT TO LEFT."
DESCRIPTION OF EVENT ACCORDING TO CATEGORIZATION FORM: [PT] ALLEGES: "CAVAL PERFORATION AND TILTING". ADDITIONAL INFORMATION RECEIVED FROM SHORT FORM COMPLAINT FILED 07JAN2019: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2010". 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 |
|---|---|---|---|---|---|---|---|
| 50410 | COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E2593242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |