UNKNOWN
Report
- Report Number
- 3002808486-2019-00664
- Event Type
- Injury
- Date Received
- May 29, 2019
- Report Date
- October 1, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THE INVESTIGATION WAS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: DEEP VEIN THROMBOSIS, MIGRATION TO [THE] DUODENUM, TILT, VENA CAVA PERFORATION, EMBEDMENT, RIGHT GROIN EDEMA AT PUNCTURE SITE, ABSCESS, DIARRHEA, LOWER EXTREMITY WEAKNESS, EDEMA IN LEFT LEG, INTERMITTENT FEVERS, ABDOMINAL DISTENTION/CONSTIPATION, OCCLUSIVE THROMBUS, PUNCTURED VEIN, LIMITED PHYSICAL ACTIVITY, PAIN, LABORED BREATHING, AND FEAR. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. 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 OR FILTER FRAGMENT MIGRATION AND (OR) EMBOLIZATION (E.G., MOVEMENT TO THE HEART OR LUNGS) HAS BEEN REPORTED. FILTER OR FILTER FRAGMENT MOVEMENT HAS OCCURRED IN BOTH THE CRANIAL AND CAUDAL DIRECTION AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS SMALLER OR LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; DEPLOYMENT INTO THROMBUS; DISLODGEMENT DUE TO LARGE THROMBUS BURDENS; 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: FILTER MIGRATION, TRAUMA TO ADJACENT STRUCTURES. 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. 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. A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. FOR ALL RETRIEVABLE IVC FILTERS, RETRIEVAL BECOMES MORE CHALLENGING WITH TIME, AND THIS IS COMMONLY DUE TO ENCAPSULATION OF THE FILTER LEGS OR HOOK (IN A TILTED FILTER) BY TISSUE INGROWTH. UNKNOWN IF THE REPORTED RIGHT GROIN EDEMA AT PUNCTURE SITE, ABSCESS, DIARRHEA, LOWER EXTREMITY WEAKNESS, EDEMA IN LEFT LEG, INTERMITTENT FEVERS, ABDOMINAL DISTENTION/CONSTIPATION, PUNCTURED VEIN, LIMITED PHYSICAL ACTIVITY, PAIN, LABORED BREATHING, AND FEAR ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN 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 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.
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. DEVICE CODE(S): APPROPRIATE TERM/CODE NOT AVAILABLE (3191) WAS SELECTED FOR THE ALLEGED PERFORATION AND DEVICE TILT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF 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). 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.
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.
ADDITIONAL INFORMATION RECEIVED ON 03JUN2019: PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2014 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO PROPHYLAXIS FOR BLOOD CLOTS DUE TO A STROKE (PROLONGED HOSPITALIZATION AFTER A RIGHT HEMORRHAGIC CVA)/ LARGE THROMBUS CLOGGED THE OTHER MANUFACTURER'S DEVICE. PATIENT IS ALLEGING MIGRATION TO [THE] DUODENUM, TILT, VENA CAVA PERFORATION, EMBEDMENT, PUNCTURED VEIN, RIGHT GROIN EDEMA AT PUNCTURE SITE, ABSCESS, DIARRHEA, LOWER EXTREMITY WEAKNESS, EDEMA IN LEFT LEG, INTERMITTENT FEVERS, ABDOMINAL DISTENTION/CONSTIPATION, OCCLUSIVE THROMBUS, AND LIMITED PHYSICAL ACTIVITY. THE PATIENT FURTHER ALLEGES A SUCCESSFUL RETRIEVAL OF THE IMPLANT VIA THE RIGHT INTERNAL JUGULAR VEIN ON (B)(6) 2018 DUE TO EMBEDMENT OF THE IMPLANT TIP AND NO LONGER NEEDING THE FILTER. THE PATIENT FURTHER ALLEGES LLE DVT (LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS), A SECOND HEMORRHAGIC CVA (CEREBROVASCULAR ACCIDENT), "I HAVE PAIN IN MY STOMACH, MY BREATHING IS LABORED, FEELS HEAVY. I AM STILL VERY WORRIED AND STRESSED ABOUT THE PERFORATED VEIN AND THE DAMAGE DONE FOR THE REMOVAL OF THE IVC FILTER.", AND FEAR OF FUTURE FRACTURE AND/OR MIGRATION OR ORGAN PERFORATION PRIOR TO REMOVAL. PATIENT WAS REPORTEDLY IMPLANTED WITH ANOTHER MANUFACTURER'S VENA CAVA FILTER ON (B)(6) 2012 DUE TO RIGHT POPLITEAL DEEP VENOUS THROMBOSIS/RIGHT-SIDED M1 OCCLUSIION WITH INABILITY TO ANTICOAGULATED IN THE SETTING OF AN ACUTE STROKE. LARGE THROMBUS CLOGGED THE OTHER MANUFACTURER'S DEVICE WHICH LED TO IMPLANTATION OF THE COOK FILTER. PER A SUCCESSFUL RETRIEVAL REPORT DATED (B)(6) 2018, "CELECT FILTER REMOVED VIA RIGHT JUGULAR ACCESS USING ENDOBRONCHIAL FORCEPS. [OTHER MANUFACTURER'S] FILTER REMOVED VIA RIGHT FEMORAL VEIN ACCESS USING ENDO BRONCHIAL FORCEPS. MACERATION OF SMALL AMOUNT OF WALL ADHERENT MATERIAL PERFORMED FOLLOWING FILTER REMOVAL."
'IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2014". 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 |
|---|---|---|---|---|---|---|---|
| 445782 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |