TREVO NXT 6MM X 30MM - CE

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RETRIEVER GOT STUCK IN THE CATHETER AND WHEN THE PHYSICIAN TRIED TO MANIPULATE IT THE PART OF THE SUBJECT STENT BROKE OFF. THE STENT WAS LEFT INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE CORE WIRE WAS RETURNED WITH 2 NON STRYKER CATHETERS. THE CORE WIRE WAS SEEN TO BE BROKEN AND THE RETRIEVER SHAPED SECTION DETACHED. THE RETRIEVER SHAPED SECTION WAS SEEN TO BE BROKEN, HOWEVER THIS WAS BROKEN DURING ANALYSIS WHILE REMOVING FROM THE CATHETER. THE RETRIEVER SHAPED SECTION WAS SEEN TO BE BADLY DAMAGED AND THERE WERE PROCEDURAL FLUIDS PRESENT ALONG THE SHAPED SECTION. DURING FUNCTIONAL INSPECTION, BOTH NON STRYKER CATHETERS WERE FLUSHED AND PATENCY MANDRELS WERE ADVANCED THROUGH IN AN ATTEMPT TO LOCATE THE DETACHED RETRIEVER. ONE OF THE CATHETERS HAD TO BE CUT AT THE POINT THE MANDREL WOULD NOT ADVANCE FURTHER AND THE RETRIEVER SHAPED SECTION WAS REMOVED FROM THE CATHETER FOR ANALYSIS. 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 FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. IT WAS REPORTED THAT THE SUBJECT RETRIEVER GOT STUCK IN THE CATHETER AND THE STENT BROKE OFF DURING MANIPULATION INSIDE THE CATHETER. DURING ANALYSIS, THE CORE WIRE WAS FOUND TO BE BROKEN AND DETACHED FROM THE RETRIEVER SHAPED SECTION. AFTER FLUSHING THE CATHETERS AND ADVANCING PATENCY MANDRELS TO LOCATE THE DETACHED RETRIEVER, ONE OF THE CATHETERS HAD TO BE CUT TO REMOVE THE STENT. THE RETRIEVER SHAPED SECTION WAS FOUND TO BE BADLY DAMAGED (BENT, BUCKLED, MANGLED) AND THERE WERE PROCEDURAL FLUIDS PRESENT ALONG THE SHAPED SECTION. THE REPORTED RETRIEVER FRACTURE/BROKEN DURING USE WAS NOT CONFIRMED AS THE SHAPED SECTION WAS NOT RETURNED BROKEN. NOTE: THE RETRIEVER SHAPED SECTION FRACTURED DURING ANALYSIS WHILE REMOVING IT FROM THE CATHETER AND THEREFORE WILL NOT BE ADDED TO THE AS ANALYZED CODES. IT IS PROBABLE THAT THE SUBJECT DEVICE FRACTURED WHEN IT GOT STUCK IN THE CATHETER. IT IS PROBABLE THAT THERE WERE PROCEDURAL AND/OR ANATOMICAL FACTORS PRESENT DURING THE CLINICAL PROCEDURE WHICH CAUSED THE EVENT. THEREFORE, AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS ANALYZED 'RETRIEVER CORE WIRE BROKEN DURING USE' AND 'RETRIEVER SHAPED SECTION DAMAGE' 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 PROCEDURE, THE SUBJECT STENT RETRIEVER GOT STUCK IN THE CATHETER AND WHEN THE PHYSICIAN TRIED TO MANIPULATE IT THE PART OF THE SUBJECT STENT BROKE OFF. THE STENT WAS LEFT INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.