TREVO NXT 4MM X 41MM - US

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE CAT 7 CATHETER, MARKSMAN (MEDTRONIC MICROCATHETER), (B)(4) (ASAHI INTEC. GUIDEWIRE) WERE USED TO PLACE A MICROCATHETER INTO M1 AND ADVANCED CAT 7 CATHETER. HOWEVER, BECAUSE OF SEVERE MEANDERING ANATOMY, THE PRODUCT WAS WORN OUT, THUS A NEW CAT 7 + PHENOM 27 (MEDTRONIC MICROCATHETER) + (B)(4) WERE USED. NO ALLEGATIONS AGAINST CAT 7 CATHETER. CAT 7 CATHETER COULD NOT BE ADVANCED MUCH, BUT PHENOM 27 MICROCATHETER COULD BE ADVANCED TO THE PERIPHERY, SO THE STENT (SUBJECT DEVICE) WAS DEPLOYED FROM THERE. AT THIS TIME, THE STENT (SUBJECT DEVICE) DEPLOYED NORMALLY, AND THERE WAS NO FEELING OF ANY STUCK NOR RESISTANCE. THE STENT (SUBJECT DEVICE) WAS INSERTED INTO THE PHENOM 27 MICROCATHETER AND WAS ABLE TO ADVANCE TO THE LESION WITHOUT ANY PARTICULAR RESISTANCE, SO IT WAS UNSHEATHED THERE. LEAVING THE STENT (SUBJECT DEVICE) IN PLACE, AN ATTEMPT WAS MADE TO REMOVE THE PHENOM 27 MICROCATHETER, HOPING THAT BY REMOVING THE PHENOM 27 MICROCATHETER, CAT 7 CATHETER WOULD BE ADVANCED, AND REMOVED THE PHENOM 27 MICROCATHETER AS USUAL. WHEN PHENOM 27 MICROCATHETER WAS REMOVED AS USUAL WITHOUT ANY RESISTANCE, THERE WAS NO WIRE THAT WAS SUPPOSED TO COME OUT, AND WHEN IT WAS CHECKED, IT WAS FOUND THAT THE STENT (SUBJECT DEVICE) HAD NOT BEEN DEFORMED AND THE DELIVERY WIRE WAS COMING OUT FROM THE PROXIMAL END OF THE MICROCATHETER THAT WAS REMOVED, AND WHEN THE DELIVERY WIRE WE REMOVED FROM THE MICROCATHETER AND CHECKED, THERE WAS NO STENT, ONLY THE DELIVERY WIRE WAS RETRIEVED. A CBCT (CONE-BEAM COMPUTED TOMOGRAPHY SYSTEMS) WAS THEN TAKEN, AND IT WAS CONFIRMED THAT THE STENT (SUBJECT DEVICE) WAS IN PLACE IN THE DEPLOYED POSITION. RETRIEVAL WITH A SNARE WAS CONSIDERED BUT NO SNARE WAS USED, AT THIS POINT, THE PROCEDURE WAS COMPLETED WITH THE STENT IN PLACE WHICH WAS SUPPOSED TO BE RETRIEVED, CONSIDERING THAT THE PATIENT WAS IN THE SAME CONDITION AS WHEN HE WAS ADMITTED (NOT RECANALIZED, BUT NO BLEEDING OR OTHER PROBLEMS HAD OCCURRED).

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE CAT 7 CATHETER, MARKSMAN (MEDTRONIC MICROCATHETER), CHIKAI-14 200CM (ASAHI INTEC. GUIDEWIRE) WERE USED TO PLACE A MICROCATHETER INTO M1 AND ADVANCED CAT 7 CATHETER. HOWEVER, BECAUSE OF SEVERE MEANDERING ANATOMY, THE PRODUCT WAS WORN OUT, THUS A NEW CAT 7 + PHENOM 27 (MEDTRONIC MICROCATHETER) + CHIKAI-14 200CM WERE USED. NO ALLEGATIONS AGAINST CAT 7 CATHETER. CAT 7 CATHETER COULD NOT BE ADVANCED MUCH, BUT PHENOM 27 MICROCATHETER COULD BE ADVANCED TO THE PERIPHERY, SO THE STENT (SUBJECT DEVICE) WAS DEPLOYED FROM THERE. AT THIS TIME, THE STENT (SUBJECT DEVICE) DEPLOYED NORMALLY, AND THERE WAS NO FEELING OF ANY STUCK NOR RESISTANCE. THE STENT (SUBJECT DEVICE) WAS INSERTED INTO THE PHENOM 27 MICROCATHETER AND WAS ABLE TO ADVANCE TO THE LESION WITHOUT ANY PARTICULAR RESISTANCE, SO IT WAS UNSHEATHED THERE. LEAVING THE STENT (SUBJECT DEVICE) IN PLACE, AN ATTEMPT WAS MADE TO REMOVE THE PHENOM 27 MICROCATHETER, HOPING THAT BY REMOVING THE PHENOM 27 MICROCATHETER, CAT 7 CATHETER WOULD BE ADVANCED, AND REMOVED THE PHENOM 27 MICROCATHETER AS USUAL. WHEN PHENOM 27 MICROCATHETER WAS REMOVED AS USUAL WITHOUT ANY RESISTANCE, THERE WAS NO WIRE THAT WAS SUPPOSED TO COME OUT, AND WHEN IT WAS CHECKED, IT WAS FOUND THAT THE STENT (SUBJECT DEVICE) HAD NOT BEEN DEFORMED AND THE DELIVERY WIRE WAS COMING OUT FROM THE PROXIMAL END OF THE MICROCATHETER THAT WAS REMOVED, AND WHEN THE DELIVERY WIRE WE REMOVED FROM THE MICROCATHETER AND CHECKED, THERE WAS NO STENT, ONLY THE DELIVERY WIRE WAS RETRIEVED. A CBCT (CONE-BEAM COMPUTED TOMOGRAPHY SYSTEMS) WAS THEN TAKEN, AND IT WAS CONFIRMED THAT THE STENT (SUBJECT DEVICE) WAS IN PLACE IN THE DEPLOYED POSITION. RETRIEVAL WITH A SNARE WAS CONSIDERED BUT NO SNARE WAS USED, AT THIS POINT, THE PROCEDURE WAS COMPLETED WITH THE STENT IN PLACE WHICH WAS SUPPOSED TO BE RETRIEVED, CONSIDERING THAT THE PATIENT WAS IN THE SAME CONDITION AS WHEN HE WAS ADMITTED (NOT RECANALIZED, BUT NO BLEEDING OR OTHER PROBLEMS HAD OCCURRED).

Additional Manufacturer Narrative

BASED ON THE RESULTS OF THE DHR (DEVICE HISTORY REVIEW) REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. DURING VISUAL INSPECTION, THE CORE WIRE WAS FRACTURED 199.8CM FROM PROX OF CORE WIRE AND THE RETRIEVER SHAPED SECTION WAS NOT RETURNED AS IT REMAINS IN THE PATIENT. THE DEVICE WAS RETURNED WITH A NON-STRYKER CATHETER AND THERE WAS BLOOD ON THE HUB. THE NON-STRYKER CATHETER WAS FOUND TO BE DAMAGED. A FUNCTIONAL TEST WAS NOT REQUIRED AS THE FRACTURE WAS CONFIRMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE EVENT WAS CONFIRMED BASED ON THE DAMAGE NOTED TO THE RETURNED DEVICE. THE DEVICE WAS RETURNED, AND IT WAS CONFIRMED THAT THE RETRIEVER CORE WIRE WAS FRACTURED PROXIMAL TO THE STENT PORTION OF THE RETRIEVER. ADDITIONAL INFORMATION AND IMAGES PROVIDED BY CUSTOMER CONFIRMED THE STENT PORTION OF THE RETRIEVER WAS LEFT IN THE PATIENT ANATOMY. BASED ON THE CONDITION OF THE RETURNED DEVICES AND THE PROVIDED IMAGES, THE SUBJECT DEVICE MAY HAVE FRACTURED DUE TO THE SEVERE MEANDERING ANATOMY. IT IS PROBABLE THAT THERE WERE PROCEDURAL AND/OR ANATOMICAL FACTORS PRESENT DURING THE CLINICAL PROCEDURE WHICH CAUSED THE EVENT. AN ASSIGNABLE CAUSE OF 'PROCEDURAL FACTORS' WILL BE ASSIGNED TO THE AS REPORTED ¿UN-RETRIEVED DEVICE FRAGMENTS¿ AND THE AS REPORTED/AS ANALYZED CODE 'RETRIEVER CORE WIRE BROKEN DURING USE', AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.