COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2018-01194
- Event Type
- Injury
- Date Received
- October 17, 2018
- Report Date
- June 26, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
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) 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). F10) PATIENT CODE:VESSELS, PERFORATION OF (2135)-LISTED IN IFU, ORGAN(S), PERFORATION OF (1987)-NOT LISTED IN IFU, THROMBOSIS (2100)- LISTED IN THE IFU. DEVICE CODE: NO CODE AVAILABLE (3191)-TILT-LISTED IN THE IFU, NO CODE AVAILABLE (3191)- DEVICE PERFORATION- LISTED IN IFU. 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). NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI), 400 DANIELS WAY, BLOOMINGTON, IN 47404, REGISTRATION NO.: 3005580113 . ADDITIONAL INFORMATION: 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. 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 DVT IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. NO RELEVANT NOTES ON NEITHER DEVICE OR LOT NUMBER. 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 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.
INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. PER QUALITY ENGINEERING REVIEW, THE ADDITIONAL INFORMATION PROVIDED FOR THIS COMPLAINT DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSION. THEREFORE, NO NEW INVESTIGATION ACTIVITIES WILL BE CONDUCTED AT THIS TIME. COOK WILL REOPEN THE INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. (B)(4) IN LOT. THE ASSOCIATED WORK ORDER WAS REVIEWED. NO RELATED/RELEVANT NOTES WERE DOCUMENTED. ONE OTHER COMPLAINT ON 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. 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 REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A CELECT FILTER ON (B)(6) 2016". PATIENT OUTCOME: 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 (B)(6) 2016 DUE TO POST BLEED. PATIENT ALLEGES TILT, VENA CAVA PERFORATION, ORGAN PERFORATION, DEEP VEIN THROMBOSIS, CAVAL THROMBOSIS. PATIENT FURTHER ALLEGES SEVERAL SURGERIES DUE TO CLOTS IN LUNGS/HEART, STENTS, MENTAL BREAKDOWN. (B)(6) 2018, CT REVEALED: "THERE IS AN IVC FILTER PRESENT IN THE INFERIOR VENA CAVA POSITIONED JUST BELOW THE RENAL VEINS. THE PROXIMAL ASPECT OF THE FILTER HAS TILTED TO THE LEFT AND HAS PROBABLY PERFORATED THE WALL OF THE INFERIOR VENA CAVA. THE TWO RIGHT HAD STRUTS HAVE PERFORATED THROUGH THE WALL OF THE CAV. THE FILTER IS POSITIONED AT AN ANGLE OF ABOUT 30 DEGREES WITH THE PROXIMAL ASPECT OF THE LEFT AND HE STRUTS TO THE RIGHT. "
NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.
PER COMPUTED TOMOGRAPHY REPORT, "FILTER TYPE: COOK CELECT." "FILTER POSITION: BELOW ABOVE THE RENAL VEINS." "FILTER TILT: YES." "FILTER PENETRATION: YES." "IMPRESSIONS: THE FILTER IS TILTED TO THE LEFT WITH ITS PROXIMAL CONE 7 MM THROUGH THE IVC WALL. CORONAL IMAGE 51. THE ANTERIOR STRUT PENETRATES 8 MM THROUGH THE IVC WALL. IT PENETRATES INTO THE DUODENUM. SAGITTAL IMAGE 107. THE LEFT STRUT PENETRATES 0 MM THROUGH THE IVC WALL. CORONAL IMAGE 54. THE POSTERIOR STRUT PENETRATES 11 MM THROUGH THE IVC WALL. SAGITTAL IMAGE 108. THE RIGHT STRUT PENETRATES 11 MM THROUGH THE IVC WALL. CORONAL IMAGE 51."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 814900 | COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Life Threatening |