UNKNOWN
Report
- Report Number
- 3002808486-2024-00259
- Event Type
- Injury
- Date Received
- December 12, 2024
- Report Date
- December 12, 2024
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
MANUFACTURERS REF#: (B)(4). AFTER INVESTIGATION, THIS PR# HAS BEEN REPORTABLE BASED IN INVESTIGATION COMPLETE 06DEC2024. D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT PLATINUM FILTER. G5) PMA/510(K) K233680. SUMMARY OF INVESTIGATIONAL FINDINGS: A CELECT-PT FILTER WAS PLACED ¿BEFORE RADICAL GASTRECTOMY¿. DUE TO EMBEDDED FILTER HOOK SEVEN WEEKS LATER THE FILTER WAS RETRIEVED DURING ADVANCED ENDOVASCULAR RETRIEVAL TECHNIQUES AFTER UNSUCCESSFUL RETRIEVAL ATTEMPTS BY COOK AND NON-COOK RETRIEVAL DEVICES. BASED ON THE INFORMATION PROVIDED IN THE ARTICLE THE EXACT REASON FOR THE FILTER POSITION REQUIRING ADVANCED RETRIEVAL TECHNIQUE CANNOT BE DETERMINED, BUT IT IS NOTED THAT THE FILTER WAS PLACED PROPHYLACTIC. ACCORDING TO INSTRUCTIONS FOR USE THE CELECT-PT IS INTENDED FOR PREVENTION OF RECURRENT PULMONARY EMBOLISM VIA PLACEMENT IN THE VENA CAVA IN THE FOLLOWING SITUATIONS: PULMONARY THROMBOEMBOLISM WHEN ANTICOAGULANT THERAPY IS CONTRAINDICATED FAILURE OF ANTICOAGULANT THERAPY IN THROMBOEMBOLIC DISEASES EMERGENCY TREATMENT FOLLOWING MASSIVE PE WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED; AND CHRONIC, RECURRENT PE WHERE ANTICOAGULANT THERAPY HAS FAILED OR IS CONTRAINDICATED. 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. PHYSICIAN PRACTICE GUIDELINES AND PUBLISHED GUIDANCE FROM REGULATORY AGENCIES RECOMMEND THAT PATIENTS WITH INDWELLING FILTERS UNDERGO ROUTINE FOLLOW-UP. THE RISKS/BENEFITS OF FILTER RETRIEVAL SHOULD BE CONSIDERED FOR EACH PATIENT DURING FOLLOW-UP. ONCE PROTECTION FROM PE IS NO LONGER NECESSARY, FILTER RETRIEVAL SHOULD BE CONSIDERED. FILTER RETRIEVAL SHOULD BE ATTEMPTED WHEN FEASIBLE AND CLINICALLY INDICATED. FILTER RETRIEVAL IS A PATIENT-SPECIFIC, CLINICALLY COMPLEX DECISION; THE DECISION TO REMOVE A FILTER SHOULD BE BASED ON EACH PATIENT¿S INDIVIDUAL RISK/BENEFIT PROFILE (E.G., A PATIENT¿S CONTINUED NEED FOR PROTECTION FROM PE COMPARED TO THEIR EXPERIENCE WITH AND (OR) ONGOING RISK OF EXPERIENCING FILTER-RELATED COMPLICATIONS). THE FILTER IS DESIGNED TO BE RETRIEVED WITH THE GÜNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. IT MAY ALSO BE RETRIEVED WITH THE CLOVERSNARE® VASCULAR RETRIEVER. COOK HAS NOT PERFORMED TESTING TO EVALUATE THE SAFETY OR EFFECTIVENESS OF FILTER RETRIEVAL USING OTHER RETRIEVAL SYSTEMS OR TECHNIQUES. THE PUBLISHED CLINICAL LITERATURE INCLUDES DESCRIPTIONS OF ALTERNATIVE TECHNIQUES FOR FILTER RETRIEVAL; USE OF THESE TECHNIQUES VARIES ACCORDING TO PHYSICIAN EXPERIENCE, PATIENT ANATOMY, AND FILTER POSITION. THE SAFETY OR EFFECTIVENESS OF THESE ALTERNATIVE RETRIEVAL TECHNIQUES HAS NOT BEEN ESTABLISHED. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: FIRST ATTEMPT AT INFERIOR VENA CAVA (IVC) FILTER RETRIEVAL 7 WEEKS AFTER THE INSERTION FAILED DESPITE ATTEMPTS WITH IVC FILTER RETRIEVAL SET AND THE USE OF 7 FRENCH (FR) EN SNARE ENDOVASCULAR SNARE SYSTEM DESPITE MULTIPLE ATTEMPTS. COMPUTED TOMOGRAPHY (CT) SCAN SHOWED THE IVC FILTER CLOSELY ABUTTING THE ANTERIOR WALL OF THE IVC WITH SUSPICION OF THE HOOK OF FILTER BEING EMBEDDED AT THE ANTERIOR WALL OF IVC. WITH RIGHT INTERNAL JUGULAR VEIN PUNCTURE, 16FR 45 CM PERFORMER SHEATH WAS INSERTED WITH TIP AT IVC, 5FR MULTISIDE HOLES STRAIGHT CATHETER WAS PUT IN FOR VENOGRAM. TWO LOOP-WIRES WERE MADE WITH 5FR RIM CATHETER AND 260 CM TERUMO J GUIDEWIRE AND THEN SNARED WITH 7FR EN SNARE, BOTH ENDS WERE BROUGHT OUT FROM THE 16FR SHEATH. 7FR DESTINATION SHEATH WAS THEN INSERTED THROUGH ONE SET OF LOOP-WIRE AND ENGAGED THE BODY OF FILTER. ATTEMPTED HOOK CAPTURE BY DOUBLE SHEATH TECHNIQUE WHILE APPLYING TENSION TO LOOP-WIRE WAS NOT SUCCESSFUL. ATTEMPTED HOOK/HEAD CAPTURE BY 7FR ENDOMYOCARDIAL BIOPSY FORCEPS ALSO WAS NOT SUCCESSFUL. THE EMBEDDED FILTER HOOK WAS FINALLY DISSECTED OUT FROM THE IVC WALL BY 16FR SHEATH WHILE APPLYING TENSION TO THE TWO SETS OF LOOP-WIRE, WITH THE SUPPORT OF 7FR DESTINATION SHEATH. HOOK OF THE IVC FILTER WAS THEN SNARED WITH 4FR 10 MM AMPLATZ GOOSE NECK SNARE AND FILTER WAS SUCCESSFULLY RETRIEVED WITHIN THE 16FR SHEATH. THE WHOLE SYSTEM (16FR PERFORMER SHEATH, TWO SET OF LOOP-WIRE PLUS 7FR DESTINATION SHEATH, 4FR GOOSE NECK SNARE PLUS IVC FILTER) WAS REMOVED EN BLOC OVER 0.035 AMPLATZ GUIDEWIRE. A NEW 16FR SHEATH EXCHANGED TO IVC WITH POST-PROCEDURE VENOGRAM AND CT SHOWED NO EXTRAVASATION. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2152150 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | UNKNOWN | UNKNOWN LOT # OF CELECT-PT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Life Threatening |