TREVO NXT 4MM X 41MM - US

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RETRIEVER GOT STUCK IN THE INTERNAL CAROTID ARTERY AND A CAROTID-CAVERNOUS FISTULA WAS CREATED. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT STENT RETRIEVER WAS NOT RETURNED FOR ANALYSIS; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTION 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 COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. IT WAS REPORTED THAT THE SUBJECT STENT RETRIEVER WAS STUCK WITHIN THE INTERNAL CAROTID ARTERY (ICA) AND A CAROTID-CAVERNOUS FISTULA (CCF) FORMED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT NO ANOMALIES WERE NOTED TO THE DEVICE AFTER REMOVAL FROM THE PACKAGING OR PRIOR TO PREPARATION, THE DEVICE WAS PREPARED AS PER THE DFU, THE MICROCATHETER WAS FLUSHED BEFORE THE RETRIEVER WAS INSERTED, CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE, THE ANATOMY WAS NOT TORTUOUS, AND FORCE WAS APPLIED TO OVERCOME RESISTANCE TO ADVANCE OR WITHDRAW THE RETRIEVER. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE AND THE SUBJECT STENT RETRIEVER WAS NOT RETURNED FOR ANALYSIS, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WAS ASSIGNED TO THE AS REPORTED CODE DIFFICULT/UNABLE TO WITHDRAW RETRIEVER. BASED UPON MEDICAL REVIEW, THE HARM OBSERVED IN THIS COMPLAINT IS ANTICIPATED IN NATURE AS PER THE DEVICE RISK ASSESSMENT. THE AS REPORTED CODE PATIENT AV FISTULA IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND PATIENT CONDITION AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE. THEREFORE, A PROBABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RETRIEVER GOT STUCK IN THE INTERNAL CAROTID ARTERY AND A CAROTID-CAVERNOUS FISTULA WAS CREATED. NO FURTHER INFORMATION IS AVAILABLE.