TREVO NXT 4MM X 41MM - US

Description of Event or Problem

DURING THROMBECTOMY PROCEDURE, THE SUBJECT RETRIEVER WAS USED TO REMOVE BLOOD CLOT FROM THE LEFT MCA (MIDDLE CEREBRAL ARTERY) M1 SEGMENT. PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE NIHSS (NATIONAL INSTITUTE OF HEALTH STROKE SCALE) SCORE OF 18 AND MRS (MODIFIED RANQUIN SCALE) OF 0. IT WAS REPORTED THAT DURING RETRIEVAL OF SECOND PASS AT ICA (INTERNAL CAROTID ARTERY) TERMINUS, THE SUBJECT RETRIEVER BROKE INSIDE PATIENT¿S VESSEL POSSIBLY WEAKENED JUNCTION AFTER FIRST PASS AND THE RESISTANCE ENCOUNTERED DURING ADVANCEMENT. THE PHYSICIAN TRIED TO REMOVE THE FRACTURED SUBJECT RETRIEVER WITH A SNARE DEVICE, BUT IT WAS UNSUCCESSFUL. THEREFORE, THE FRACTURED SUBJECT RETRIEVER WAS RETAINED IN VASCULATURE. THE PROCEDURE WAS COMPLETED WITH A NEW RETRIEVER DEVICE (NON-STRYKER) WITH THIRD PASS AND THE CLOT WAS SUCCESSFULLY REMOVED AND RESTORED THE BLOOD FLOW. THE ASPIRIN AND CLOPIDOGREL WERE PROVIDED TO THE PATIENT FROM CAROTID STENT. THE PATIENT HAS NO EXPERIENCED OR COMPLICATION DUE TO THE RETRIEVED FRAGMENT. THE PATIENT WAS DISCHARGED TO REHAB AND ASSESSED HAVING A NIHSS OF 2 AND MRS OF 2.

Description of Event or Problem

DURING THROMBECTOMY PROCEDURE, THE SUBJECT RETRIEVER WAS USED TO REMOVE BLOOD CLOT FROM THE LEFT MCA (MIDDLE CEREBRAL ARTERY) M1 SEGMENT. PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE NIHSS (NATIONAL INSTITUTE OF HEALTH STROKE SCALE) SCORE OF 18 AND MRS (MODIFIED RANQUIN SCALE) OF 0. IT WAS REPORTED THAT DURING RETRIEVAL OF SECOND PASS AT ICA (INTERNAL CAROTID ARTERY) TERMINUS, THE SUBJECT RETRIEVER BROKE INSIDE PATIENT¿S VESSEL POSSIBLY WEAKENED JUNCTION AFTER FIRST PASS AND THE RESISTANCE ENCOUNTERED DURING ADVANCEMENT. THE PHYSICIAN TRIED TO REMOVE THE FRACTURED SUBJECT RETRIEVER WITH A SNARE DEVICE, BUT IT WAS UNSUCCESSFUL. THEREFORE, THE FRACTURED SUBJECT RETRIEVER WAS RETAINED IN VASCULATURE. THE PROCEDURE WAS COMPLETED WITH A NEW RETRIEVER DEVICE (NON-STRYKER) WITH THIRD PASS AND THE CLOT WAS SUCCESSFULLY REMOVED AND RESTORED THE BLOOD FLOW. THE ASPIRIN AND CLOPIDOGREL WERE PROVIDED TO THE PATIENT FROM CAROTID STENT. THE PATIENT HAS NO EXPERIENCED OR COMPLICATION DUE TO THE RETRIEVED FRAGMENT. THE PATIENT WAS DISCHARGED TO REHAB AND ASSESSED HAVING A NIHSS OF 2 AND MRS OF 2.

Additional Manufacturer Narrative

D4 EXPIRATION DATE - ADDED H4 MANUFACTURING DATE ¿ ADDED H3 DEVICE EVALUATED BY MFG-H3 SUMMARY ATTACHED - UPDATED THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. A SUBJECT TREVO NXT RETRIEVER CORE WIRE WAS RETURNED WITHOUT STENT AND INTRODUCER TOOL/SHEATH. DURING ANALYSIS, THE RETURNED DEVICE WAS VISUALLY INSPECTED THE DAMAGE TO THE PEBAX PORTION (THAT COVER THE DISTAL PORTION OF THE TREVO NXT COREWIRE) WAS SEEN AT THE FRACTURE REGION. PERMANENT SET AT DISTAL END OF WIRE (BEND TO APPROXIMATELY 90 DEGREES OVER ~5 CM). SEVERE (~90 DEGREE) KINK/BEND JUST PROXIMAL TO FRACTURE SITE IN DIRECTION OF THINNER SIDE OF PEBAX JACKET . THE FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. 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. THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER AND DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO 'PROCEDURAL FACTORS' DURING USE. THEREFORE AN ASSIGNABLE CAUSE OF 'PROCEDURAL FACTORS' WILL BE ASSIGNED TO THE AS REPORTED ISSUE AND INVESTIGATION.