TREVO NXT 4MM X 41MM - US

Additional Manufacturer Narrative

BASED ON THE RESULTS OF THE DHR REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. A TREVO NXT RETRIEVER CORE WIRE WAS RETURNED WITH STENT AND INTRODUCER TOOL/SHEATH. THE REPORTED LOT NUMBER WAS CONFIRMED FROM THE RETURNED PACKAGING. DAMAGE TO THE PEBAX PORTION (THAT COVER THE DISTAL PORTION OF THE TREVO NXT CORE WIRE) WAS SEEN AT THE FRACTURE REGION. ON VISUAL INSPECTION, NO VISUAL DEFECTS FOUND ON INTRODUCER SHEATH/TOOL AND STENT FRAGMENT. FRACTURE VISIBLE ON CORE WIRE NEAR DISTAL END OF PEBAX SLEEVE/JACKET. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO CONDITION OF DEVICE. SEM ANALYSIS REVEALED SOLDER CHIPPED AT MID SOLDER JOINT, CRACK SEEN NEAR FLAT CORE WIRE AND MSJ JUNCTION, EVIDENCE OF TORSION/BENDING SEEN DISTAL OF PROXIMAL FRAGMENT AND SURFACE "CROSS-HATCHING" NOTED ON CORE WIRE. 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/AS ANALYZED CODE RETRIEVER CORE WIRE BROKEN DURING PREPARATION AND TO THE AS ANALYZED CODE RETRIEVER DELIVERY WIRE LAMINATION DAMAGE/PEELING.

Description of Event or Problem

THE SUBJECT RETRIEVER WAS RETURNED FOR ANALYSIS ON 19-NOV-2020 AND DEVICE INVESTIGATION REVEALED THAT THE LAMINATION OF THE DELIVERY WIRE OF THE SUBJECT RETRIEVER WAS PEELED DURING THE PROCEDURE. THEREFORE THIS EVENT MEETS REPORTING CRITERIA WITH AN AWARENESS DATE OF 28-JAN-2021. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.