TREVO NXT 3MM X 32MM - US

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. 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 EVENTS COULD NOT BE CONFIRMED AND IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO REMOVE FROM THE SHEATH AFTER USE. UPON INSPECTION AFTER REMOVAL, THE DEVICE WAS CRUSHED AND MANGLED AND PHYSICIAN ASKED FOR A NEW ONE. NO FURTHER INFORMATION IS AVAILABLE. THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED EVENT, HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF ALL AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE FOR THE REPORTED EVENT, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THIS COMPLAINT.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE CEREBRAL ANGIOGRAM WITH MECHANICAL THROMBECTOMY PROCEDURE, THE SUBJECT STENT RETRIEVER WAS DIFFICULT TO REMOVE FROM THE SHEATH AFTER USE. UPON INSPECTION AFTER REMOVAL, THE DEVICE WAS CRUSHED AND MANGLED.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE CEREBRAL ANGIOGRAM WITH MECHANICAL THROMBECTOMY PROCEDURE, THE SUBJECT STENT RETRIEVER WAS DIFFICULT TO REMOVE FROM THE SHEATH AFTER USE. UPON INSPECTION AFTER REMOVAL, THE DEVICE WAS CRUSHED AND MANGLED.