UNKNOWN_NEUROVASCULAR_PRODUCT

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED THAT THE PHYSICIAN WAS TALKING ABOUT A CASE WITH THE VESSEL PERFORATION WHERE HE MENTIONED ABOUT THE SUBJECT STENT RETRIEVER AND OTHER ASSOCIATED DEVICES. IT IS NOT CONFIRMED IF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

Additional Manufacturer Narrative

ALTHOUGH THE DHR COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER REMAINS UNKNOWN, THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE VISUAL AND FUNCTIONAL INSPECTION WERE NOT 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 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. BASED UPON MEDICAL REVIEW, THE HARM OBSERVED IN THIS COMPLAINT IS ANTICIPATED IN NATURE AS PER THE DEVICE RISK ASSESSMENT. AS A PRODUCT RELATED ROOT CAUSE DOES NOT APPLY AND THE ISSUE IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND/OR PATIENT CONDITION NOTED WITHIN THE DFU, PRODUCT LABELING AND/OR RISK DOCUMENTATION FILES, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THIS COMPLAINT OF PATIENT VESSEL PERFORATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PHYSICIAN WAS TALKING ABOUT A CASE WITH THE VESSEL PERFORATION WHERE HE MENTIONED ABOUT THE SUBJECT STENT RETRIEVER AND OTHER ASSOCIATED DEVICES. IT IS NOT CONFIRMED IF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. NO ADDITIONAL INFORMATION AVAILABLE.