TREVO NXT 6MM X 37MM - US

Description of Event or Problem

IT WAS REPORTED THAT DURING THE MECHANICAL THROMBECTOMY PROCEDURE, THE PHYSICIAN DEPLOYED THE SUBJECT STENT RETRIEVER AT THE INTERNAL CAROTID ARTERY. WHILE WITHDRAWING, THE CORE WIRE OF THE SUBJECT STENT RETRIEVER WAS BROKEN INSIDE THE PATIENT ANATOMY. A SNARE STENT WAS USED TO RETRIEVE THE BROKEN PART. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL/MICROSCOPIC INSPECTION, THE RETRIEVER WAS RETURNED WITH ANOTHER RETRIEVER. THE RETRIEVER SHAPED SECTION WAS TRAPPED IN ANOTHER RETRIEVER SHAPED SECTION AND, DESPITE EFFORTS, COULD NOT BE REMOVED. THEY WERE BOTH INTACT. THE CORE WIRE WAS SEEN TO BE BROKEN AT THE DISTAL END OF THE DEVICE, APPROX. 11CM FROM THE DISTAL END. THE BROKEN DISTAL END OF THE CORE WIRE WAS SEEN TO BE KINKED. THE INSERTION TOOL WAS NOT RETURNED. FUNCTIONAL INSPECTION COULD NOT BE PERFORMED DUE TO THE CONDITION THE DEVICE WAS RECEIVED. 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 DEVICE WAS INTENDED TO BE USED FOR TREATMENT. THE PRODUCT WAS RETURNED, AND THE AS ANALYZED CODES ¿RETRIEVER CORE WIRE BROKEN DURING USE¿ AND ¿RETRIEVER CORE WIRE KINKED¿ WERE FOUND. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. ALL COMPONENTS OF THE DEVICE WERE RETURNED FOR INVESTIGATION. THE DEVICE WAS RECEIVED, DECONTAMINATED, INSPECTED, MEASURED, AND IMAGED. UPON REVIEW OF THE RETURNED WIRE THERE WAS STRETCHING NOTED ON THE POLYMER JACKET AT THE DISTAL END, WHICH IS INDICATIVE THAT SOME STRESSES MAY HAVE BEEN EXERTED ON THE WIRE THAT COULD HAVE CONTRIBUTED TO THE FRACTURE. A REVIEW OF THE RECEIVED INFORMATION NOTED THAT RESISTANCE WAS EXPERIENCED DURING THE PROCEDURE WITHIN THE MICROCATHETER. ACCORDING TO THE REPORT OF THE EVENT, THERE WAS RESISTANCE ENCOUNTERED WHEN AN ATTEMPT WAS MADE TO PULL BACK THE RETRIEVER, WHICH MAY INDICATE THAT THE FRACTURE OCCURRED DURING THE WITHDRAWAL USE STEP WHILE EXPERIENCING RESISTANCE, ALTHOUGH IT IS NOT POSSIBLE TO DEFINITIVELY MAKE THIS DETERMINATION BASED ON CURRENTLY AVAILABLE INFORMATION. THEREFORE, AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED 'RETRIEVER CORE WIRE BROKEN DURING USE' AND 'RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT' AND AS ANALYZED DEFECTS ¿ RETRIEVER CORE WIRE BROKEN DURING USE¿ AND ¿RETRIEVER CORE WIRE KINKED' SINCE THESE ISSUES ARE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE MECHANICAL THROMBECTOMY PROCEDURE, THE PHYSICIAN DEPLOYED THE SUBJECT STENT RETRIEVER AT THE INTERNAL CAROTID ARTERY. WHILE WITHDRAWING, THE CORE WIRE OF THE SUBJECT STENT RETRIEVER WAS BROKEN INSIDE THE PATIENT ANATOMY. A SNARE STENT WAS USED TO RETRIEVE THE BROKEN PART. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.