TREVO NXT 3MM X 32MM - US
Received Feb 27, 2023 · Event occurred Feb 1, 2023
Report 3012931345-2023-00028 · MDR key 16444195
Device
Generic name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Manufacturer
Stryker Neurovascular-utah-salt Lake CityModel number
90312Catalog number
90312
Lot number
0000063063
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT RETRIEVER IN THE MICROCATHETER AND THE DELIVERY WIRE BROKE WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE SUBJECT DEVICE AND THE RETRIEVER GOT STUCK IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND RETRIEVER AND REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
Additional Manufacturer Narrative
THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS VISUAL TESTING CANNOT 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 EVENT WAS UNABLE TO BE CONFIRMED AND IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. IT WAS REPORTED THAT WHILE TRYING TO PLACE THE SUBJECT RETRIEVER STENT INTO THE MICROCATHETER THERE WAS A LOT OF RESISTANCE WHILE PUSHING. WHEN THE PHYSICIAN TRIED TO RETRACT THE RETRIEVER STENT, THE DELIVERY WIRE BROKE AND THE RETRIEVER STENT GOT STUCK IN THE MICROCATHETER. ADDITIONAL INFORMATION STATES THAT THE DEVICE WAS PREPARED AS PER THE DFU, THE PATIENTS ANATOMY WAS MODERATELY TORTUOUS AND CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE AVAILABLE INFORMATION FAILS TO INDICATE A PROBABLE CAUSE FOR THE REPORTED EVENT, THEREFORE AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THIS COMPLAINT.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT RETRIEVER IN THE MICROCATHETER AND THE DELIVERY WIRE BROKE WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE SUBJECT DEVICE AND THE RETRIEVER GOT STUCK IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND RETRIEVER AND REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.