GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED IN THE LITERATURE, DURING RETRIEVAL OF A COOK CELECT PLATINUM VENA CAVA FILTER, THE FILTER COULD NOT BE SNARED WITH THE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET, AS THE FILTER WAS TILTED 20-30 DEGREES AND THE FILTER HOOK WAS NOT ACCESSIBLE. THE FILTER COLLET WAS REPORTEDLY CAPTURED USING THE LOOP-SNARE TECHNIQUE AND THE FILTER WAS COLLAPSED INTO THE RETRIEVAL SHEATH. THE INNER CATHETER/SHEATH OF THE COAXIAL SYSTEM WAS NOT USED DURING FILTER RETRIEVAL; THEREFORE, ONLY THE OUTER SHEATH WAS ADVANCED OVER THE FILTER PRIOR TO ATTEMPTED REMOVAL. MILD RESISTANCE WAS ENCOUNTERED WHEN THE FILTER WAS APPROXIMATELY HALFWAY THROUGH THE SHEATH. AT THAT TIME, IT WAS NOTED THAT THE TIP/HOOK OF THE FILTER HAD PERFORATED THE SHEATH, WHICH APPEARED TO BE BENT IN THE REGION OF THE PERFORATION. AFTER USING A BALLOON TO PULL THE SHEATH, THE ENTIRE DEVICE AND FILTER WERE REMOVED FROM FEMORAL VEIN. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. NO DEVICE WAS RETURNED FOR ANALYSIS, HOWEVER, THE ILLUSTRATIONS AND AN INTRA-OPERATIVE FLUOROSCOPY IN THE ARTICLE SHOWED THE ADVANCED LOOP-WIRE TECHNIQUE USED TO COLLAPSE THE TILTED FILTER INSIDE THE BLUE RETRIEVAL SHEATH AND HOW THE FILTER HOOK HAD PENETRATED THE BENT SHEATH. ACCORDING TO THE FLUOROSCOPY, THE FILTER HOOK HAD PENETRATED THE SHEATH MORE THAN 15CM FROM THE MOST DISTAL TIP, BUT THERE IS NO INDICATION WHY THE FILTER WAS PULLED THAT FAR INTO THE SHEATH AND NOT REMOVED FROM THE JUGULAR VEIN, WHEN COLLAPSED IN THE DISTAL END OF THE SHEATH. IT IS NOTED THAT SOME OF THE ILLUSTRATIONS SHOWED A TILTED TULIP FILTER, BUT REPORTEDLY THE PATIENT HAD A CELECT-PT FILTER IMPLANTED. COOK WAS UNABLE TO CONDUCT REVIEWS OF THE DEVICE HISTORY RECORD OR COMPLAINT HISTORY, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS CONCLUDED THAT THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS MANUFACTURED TO SPECIFICATIONS. COOK CONDUCTED A REVIEW OF NON-CONFORMANCES FROM 01JAN2019 TO 27FEB2022 AND FOUND NO NON-CONFORMANCES RELATED TO THIS COMPLAINT. THE IFU FOR THIS DEVICE WARNS THAT EXCESSIVE FORCE SHOULD NOT BE USED TO RETRIEVE THE FILTER. THE IFU STATES THAT THE CELECT FILTER CAN BE COMPLETELY COLLAPSED IN THE INNER SHEATH PRIOR TO ADVANCING THE OUTER SHEATH. THE IFU CAUTIONS THAT PRODUCT MODIFICATION OR ALTERATION IS NOT RECOMMENDED, AS SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOLLOWING MODIFICATIONS. THE IFU SAYS THAT RETRIEVAL BECOMES MORE CHALLENGING WITH TIME AND IS COMMONLY ASSOCIATED WITH FILTER LEG OR HOOK INGROWTH. THE IFU STATES, ¿DO NOT RETRACT THE RETRIEVAL LOOP SYSTEM UNTIL THE TIP OF THE COAXIAL RETRIEVAL SHEATH IS AT THE FILTER ANCHORS. DOING SO MAY CAUSE DAMAGE TO THE CAVAL WALL.¿ WHEN THE TIP OF THE COAXIAL SHEATH IS AT THE FILTER ANCHORS, THE IFU THEN INSTRUCTS TO ADVANCE THE OUTER SHEATH FORWARD TO COVER THE ENTIRE FILTER. THE IFU ADDRESSES ALTERNATIVE TECHNIQUES FOR FILTER RETRIEVAL AND SAYS THAT THE SAFETY AND EFFECTIVENESS OF ALTERNATE RETRIEVAL TECHNIQUES HAVE NOT BEEN ESTABLISHED. WITH CURRENT INFORMATION, THE CAUSE FOR THIS EVENT CAN LIKELY BE TRACED TO CONCOMITANT DEVICES AND USER/PROCEDURAL ISSUES. IT IS KNOWN THAT THE CELECT-PT FILTER WAS TILTED 20-30 DEGREES AND THE FILTER HOOK WAS NOT ACCESSIBLE DUE TO IN-GROWTH WITHIN THE VENA CAVA. ATTEMPTS TO RETRIEVE THE FILTER USING OTHER METHODS WERE UNSUCCESSFUL. ADDITIONALLY, THE COMPLAINT DEVICE WAS USED FOR A LOOP-SNARE TECHNIQUE, WHICH IS CONSIDERED AN ALTERNATIVE RETRIEVAL TECHNIQUE, PER THE IFU. THE INNER CATHETER/SHEATH OF THE COAXIAL SYSTEM WAS NOT USED DURING ATTEMPTED RETRIEVAL, AS INSTRUCTED IN THE IFU; THEREFORE, THE COAXIAL SYSTEM WAS NOT USED TO COLLAPSE AND COVER THE FILTER TO THE FILTER ANCHORS. THE 11 FRENCH OUTER SHEATH, WHICH APPEARED TO HAVE BENT, WAS ADVANCED OVER THE FILTER, WHICH WAS REPORTEDLY ALREADY TILTED. IT IS UNLIKELY THAT THE FILTER WAS COMPLETELY COLLAPSED WITHIN THE LARGER OUTER SHEATH. WHEN THE SYSTEM IS USED AS INSTRUCTED, THE HOOK OF THE COLLAPSED FILTER IS KEPT UPRIGHT WITHIN THE INNER SHEATH. BECAUSE THE FILTER WAS NOT SECURED WITHIN THE INNER CATHETER, IT IS LIKELY THAT THE FILTER REMAINED SOMEWHAT TILTED AS THE OUTER SHEATH WAS ADVANCED OVER IT, WHICH COULD HAVE MADE PERFORATION BY THE HOOK POSSIBLE IN THE BEND. THEREFORE, THE FILTER HOOK PENETRATING THE SHEATH IS CONSIDERED OFF LABEL USE AS A CONSEQUENCE OF THE RETRIEVAL LOOP NOT CATCHING THE HOOK OF THE TILTED FILTER. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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 or Problem

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Additional Manufacturer Narrative

CITATION: WINRICH, E.J., SIGDEL, A., DWIVDEI, A. J., & WAYNE, E.J. (2020). ENDOVASCULAR RESCUE OF SHEATH PERFORATION DURING INFERIOR VENA CAVA FILTER RETRIEVAL. EJVES VASCULAR FORUM, 49, 40-44. HTTPS://DOI.ORG/10.1016/J.EJVSVF.2020.11.002. PMA/510(K) NUMBER = K181757. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Description of Event or Problem

AS REPORTED IN THE LITERATURE, A (B)(6) MALE UNDERWENT A PROCEDURE TO RETRIEVE A COOK CELECT PLATINUM VENA CAVA FILTER THAT HAD BEEN IN PLACE FOR TEN MONTHS. THE FILTER HAD BEEN PLACED WITHOUT COMPLICATION, VIA STANDARD FEMORAL APPROACH, PRIOR TO AN ABDOMINOPERINEAL RESECTION FOR RECTAL CANCER. THE DECISION WAS MADE TO RETRIEVE THE FILTER, AS THE PATIENT WAS ABLE TO RESUME ANTICOAGULANT THERAPY. A COOK GTRS WAS ADVANCED VIA RIGHT INTERNAL JUGULAR APPROACH. REPORTEDLY, INITIAL ATTEMPTS AT SNARING THE FILTER HOOK USING GOOSENECK AND CLOVERLEAF SNARES WERE UNSUCCESSFUL, AS THE FILTER WAS SOMEWHAT TILTED. A LOOP-SNARE TECHNIQUE WAS THEN USED TO CAPTURE THE FILTER. THE AUTHORS DESCRIBE THE LOOP-SNARE TECHNIQUE AS FOLLOWS: A REVERSE-CURVE CATHETER IS ADVANCED TO BELOW THE LEVEL OF THE FILTER AND A GUIDEWIRE IS THEN DIRECTED THROUGH THE FILTER LEGS. THE END OF THE GUIDEWIRE IS THEN SNARED AND EXTERNALIZED, FORMING A LOOP THROUGH THE FILTER THAT CAN PROVIDE COUNTER TRACTION TO COLLAPSE THE FILTER INTO THE SHEATH. THE AUTHORS STATE THAT ONE COMPLICATION ASSOCIATED WITH THE LOOP-SNARE TECHNIQUE IS RE-ORIENTATION OF THE FILTER, WHICH OCCURS IF THE LOOP IS NOT FORMED DIRECTLY UNDER THE FILTER APEX AND THE WIRE IS MISPLACED, POSSIBLY CAUSING THE FILTER TO MOVE INTO A TRANSVERSE POSITION THAT COMPLICATES RETRIEVAL. THE FILTER COLLET WAS REPORTEDLY CAPTURED USING THE LOOP-SNARE TECHNIQUE, AND THE FILTER WAS COLLAPSED INTO THE RETRIEVAL SHEATH. MILD RESISTANCE WAS ENCOUNTERED WHEN THE FILTER WAS APPROXIMATELY HALFWAY THROUGH THE SHEATH. AT THAT TIME, IT WAS NOTED THAT THE TIP/HOOK OF THE FILTER HAD PERFORATED THE SHEATH, WHICH APPEARED TO BE BENT IN THE REGION OF THE PERFORATION. THE SHEATH WAS UNABLE TO BE PULLED SUPERIORLY BUT WAS ABLE TO BE PUSHED INFERIORLY WITHOUT RESISTANCE. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL VEIN AND AN UNSPECIFIED SHORT TAPER TIP AMPLATZ WIRE WAS USED TO CANNULATE THE DISTAL END OF THE PERFORATED SHEATH. AN UNKNOWN 4X6 BALLOON WAS THEN ADVANCED VIA THE FEMORAL ACCESS POINT AND WAS INFLATED WITHIN THE DISTAL END OF THE PERFORATED SHEATH. THE BALLOON WAS THEN USED TO PULL THE PERFORATED SHEATH AND FILTER INTO A LARGER, 16 FRENCH 45-CENTIMETER SHEATH INSERTED FROM THE FEMORAL VEIN. THE USER REMOVED THE TUOHY-BORST AND LUER ADAPTERS FROM THE GTRS SET AND PULLED THE SHEATH INTO THE PATIENT. THE ENTIRE DEVICE AND FILTER WERE THEN REMOVED FROM THE FEMORAL VEIN. WINRICH, E.J., SIGDEL, A., DWIVDEI, A. J., & WAYNE, E.J. (2020). ENDOVASCULAR RESCUE OF SHEATH PERFORATION DURING INFERIOR VENA CAVA FILTER RETRIEVAL. EJVES VASCULAR FORUM, 49, 40-44. HTTPS://DOI.ORG/10.1016/J.EJVSVF.2020.11.002. ADDITIONAL INFORMATION WAS RECEIVED 22 NOV 2021 FROM THE CUSTOMER. THE INNER CATHETER/SHEATH OF THE COAXIAL SYSTEM WAS NOT USED THE DURING FILTER RETRIEVAL; THEREFORE, ONLY THE OUTER SHEATH WAS ADVANCED OVER THE FILTER PRIOR TO ATTEMPTED REMOVAL. A 4 FRENCH REVERSE CURVE SHEATH, ANGLED WIRE, AND SNARE WERE USED THROUGH THE OUTER SHEATH OF THE COMPLAINT DEVICE. THE FILTER WAS TILTED 20-30 DEGREES AND THE FILTER HOOK WAS NOT ACCESSIBLE. PER THE USER, THE "ISSUES" WERE MAINLY TECHNIQUE AND THE SEVERITY OF FILTER IN-GROWTH. THE CELECT FILTER WILL BE REPORTED BY WILLIAM COOK EUROPE UNDER PATIENT IDENTIFIER (B)(6).