TREVO NXT 4MM X 41MM - US

Additional Manufacturer Narrative

B2 OUTCOMES ATTRIBUTED TO AE - CORRECTED TO INCLUDE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS). THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL/MICROSCOPIC INSPECTION, THE CORE WIRE WAS SEEN TO BE BROKEN AT THE DISTAL END OF THE DEVICE, APPROX. 193.5 FROM THE PROXIMAL END. THE RETRIEVER SHAPED SECTION WAS NOT RETURNED. THE INSERTION TOOL WAS NOT RETURNED. FUNCTIONAL INSPECTION WAS NOT REQUIRED. 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 REPORTED 'RETRIEVER FRACTURE/BROKEN DURING USE' AND 'UN-RETRIEVED DEVICE FRAGMENTS' COULD NOT BE DUPLICATED DURING DEVICE ANALYSIS; HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE RETRIEVER BROKE OFF IN THE PATIENT'S MIDDLE CEREBRAL ARTERY MCA AND WAS LEFT IN THE PATIENT'S ANATOMY. THAT THE DEVICE WAS PREPARED FOR USE AS PER THE DFU, THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. THE WIRE COMPONENT OF THE DEVICE WAS 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. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED 'RETRIEVER FRACTURE/BROKEN DURING USE' AND 'UN-RETRIEVED DEVICE FRAGMENTS' AND AS ANALYZED 'RETRIEVER CORE WIRE BROKEN DURING USE', AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, THE SUBJECT STENT RETRIEVER DELIVERY WIRE BROKE OFF DURING THIRD PASS AND PART OF THE STENT AND DELIVERY WIRE REMAINED IN THE PATIENT'S MIDDLE CEREBRAL ARTERY (M2-M1). AN ATTEMPT WAS MADE TO RETRIEVE IT WITH A SNARE DEVICE, BUT IT COULD NOT BE RETRIEVED. RECANALIZATION WAS NOT OBTAINED, AND THE PROCEDURE WAS COMPLETED LEAVING THE REMAINED BROKEN/FRACTURED DEVICES. THE PATIENT'S CONDITION IS STABLE SO FAR. THE PATIENT WAS ABLE TO SPEAK AFTER THIS EVENT. ANTIPLATELET DRUGS WERE ADDED. PHYSICIAN FELT THAT THE ANATOMY AND/OR LOCATION OF INTENDED AREA OF TREATMENT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, THE SUBJECT STENT RETRIEVER DELIVERY WIRE BROKE OFF DURING THIRD PASS AND PART OF THE STENT AND DELIVERY WIRE REMAINED IN THE PATIENT'S MIDDLE CEREBRAL ARTERY (M2-M1). AN ATTEMPT WAS MADE TO RETRIEVE IT WITH A SNARE DEVICE, BUT IT COULD NOT BE RETRIEVED. RECANALIZATION WAS NOT OBTAINED, AND THE PROCEDURE WAS COMPLETED LEAVING THE REMAINED BROKEN/FRACTURED DEVICES. THE PATIENT'S CONDITION IS STABLE SO FAR. THE PATIENT WAS ABLE TO SPEAK AFTER THIS EVENT. ANTIPLATELET DRUGS WERE ADDED. PHYSICIAN FELT THAT THE ANATOMY AND/OR LOCATION OF INTENDED AREA OF TREATMENT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

Additional Manufacturer Narrative

SEM (SCANNING ELECTRON MICROSCOPY) IMAGING WAS CONDUCTED ON THE CORE WIRE FRACTURE AND THERE WAS EVIDENCE OF BENDING STRESSES AND DUCTILE FAILURE AND TENSILE FORCES.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, THE SUBJECT STENT RETRIEVER DELIVERY WIRE BROKE OFF DURING THIRD PASS AND PART OF THE STENT AND DELIVERY WIRE REMAINED IN THE PATIENT'S MIDDLE CEREBRAL ARTERY (M2-M1). AN ATTEMPT WAS MADE TO RETRIEVE IT WITH A SNARE DEVICE, BUT IT COULD NOT BE RETRIEVED. RECANALIZATION WAS NOT OBTAINED, AND THE PROCEDURE WAS COMPLETED LEAVING THE REMAINED BROKEN/FRACTURED DEVICES. THE PATIENT'S CONDITION IS STABLE SO FAR. THE PATIENT WAS ABLE TO SPEAK AFTER THIS EVENT. ANTIPLATELET DRUGS WERE ADDED. PHYSICIAN FELT THAT THE ANATOMY AND/OR LOCATION OF INTENDED AREA OF TREATMENT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.