TREVO NXT 4MM X 41MM - CE
Received Nov 3, 2023 · Event occurred Oct 5, 2023
Report 3012931345-2023-00236 · MDR key 18069624
Device
Generic name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Manufacturer
Stryker Neurovascular-utah-salt Lake CityCatalog number
90414
Lot number
0000236024
Product problems
- Fracture
- Fracture
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H4 MANUFACTURING DATE - ADDED. D4 EXPIRATION DATE - ADDED. 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 COULD NOT BE CONFIRMED, AND IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. IT WAS REPORTED THAT WHEN RETRACTING THE STENT RETRIEVER DETACHED FROM THE DELIVERY WIRE AND STAYED STUCK IN THE MICROCATHETER. AS PER THE ADDITIONAL INFORMATION, THE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT AND CONTINUOUS FLUSH SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. THERE WAS NO FURTHER INFORMATION AVAILABLE. THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED EVENT, HOWEVER, AS THE DEVICE WAS NOT RETURNED AND A REVIEW OF ALL AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE, AN ASSIGNABLE CAUSE OF 'UNDETERMINABLE' WILL BE ASSIGNED TO THE AS REPORTED ¿RETRIEVER FRACTURE/ BROKEN DURING USE¿.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RETRIEVER DETACHED FROM THE DELIVERY WIRE AND REMAINED STUCK WITHIN THE MICROCATHETER WHILE RETRACTING AFTER THE SECOND ATTEMPT TO GET THE THROMBUS OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Additional Manufacturer Narrative
H3 OTHER TEXT : THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RETRIEVER DETACHED FROM THE DELIVERY WIRE AND REMAINED STUCK WITHIN THE MICROCATHETER WHILE RETRACTING AFTER THE SECOND ATTEMPT TO GET THE THROMBUS OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.