TREVO NXT 6MM X 37MM - US

Additional Manufacturer Narrative

THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. VISUAL AND FUNCTIONAL INSPECTIONS WERE NOT CONDUCTED DUE TO THE DEVICE WAS NOT RETURNED. 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 WERE UNABLE TO BE CONFIRMED AND IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. ADDITIONAL INFORMATION INDICATES THAT THE FRACTURE OCCURRED DURING RETRIEVAL. THE PHYSICIAN REPORTED THAT AN EXCESSIVE AMOUNT OF FORCE ON RETRIEVAL WAS NOT FELT AND THIS WAS THE FIRST RETRIEVAL ATTEMPT. THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE RETRIEVER CORE WIRE TO FRACTURE DURING USE, HOWEVER AS THE DEVICE WAS NOT RETURNED AND A REVIEW OF THE AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE FOR THE REPORTED EVENT, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THE REPORTED EVENTS: ¿RETRIEVER FRACTURED/BROKEN DURING USE¿ AND ¿UN-RETRIEVED DEVICE FRAGMENTS¿.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT STENT RETRIEVER DETACHED. A SNARE DEVICE WAS USED TO REMOVE IT FROM THE PATIENT'S ANATOMY, BUT UNSUCCESSFULLY. A SURGICAL DELAY OF UNKNOWN LENGTH WAS REPORTED DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT STENT RETRIEVER DETACHED. A SNARE DEVICE WAS USED TO REMOVE IT FROM THE PATIENT'S ANATOMY, BUT UNSUCCESSFULLY. A SURGICAL DELAY OF UNKNOWN LENGTH WAS REPORTED DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE.