TREVO NXT 6MM X 37MM - US
Received Jun 6, 2023 · Event occurred May 22, 2023
Report 3012931345-2023-00121 · MDR key 17068362
Device
Generic name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Manufacturer
Stryker Neurovascular-utah-salt Lake CityModel number
90315Catalog number
90315
Lot number
0000188995
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H3: THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, THERE WAS DIFFICULTY TO ADVANCE THE SUBJECT STENT RETRIEVER INITIALLY AND THEN IT BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. THERE WAS A SURGICAL DELAY OF 5-10 MINUTES DUE TO THE REPORTED ISSUE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. OTHER INFORMATION IS AVAILABLE.
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, VISUAL TESTING AS WELL AS FUNCTIONAL 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 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 BROKEN. AS PER THE ADDITIONAL INFORMATION, IT WAS VERY DIFFICULT TO ADVANCE THE RETRIEVER, INITIALLY. THE DEVICE WAS PREPARED AS PER THE DFU, CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE AND THERE WAS NO DAMAGE NOTED TO THE MICROCATHETER AND/OR INSERTION TOOL PRIOR TO USE. 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 REPORTED EVENT.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, THERE WAS DIFFICULTY TO ADVANCE THE SUBJECT STENT RETRIEVER INITIALLY AND THEN IT BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. THERE WAS A SURGICAL DELAY OF 5-10 MINUTES DUE TO THE REPORTED ISSUE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. O OTHER INFORMATION IS AVAILABLE.