TREVO NXT 6MM X 37MM - US
Report
- Report Number
- 3012931345-2023-00073
- Event Type
- Injury
- Date Received
- April 26, 2023
- Date of Event
- April 1, 2023
- Report Date
- July 26, 2023
- Manufacturer
- STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
- Product Code
- POL
- UDI-DI
- 07613327299953
- PMA / PMN Number
- K200117
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE RETRIEVER SHAPED SECTION WAS NOTED TO HAVE BEEN BROKEN/FRACTURED FROM THE CORE WIRE AT 9.5 CM FROM THE MSJ (MID SOLDER JOINT) TO PEBAX TRANSITION. THE PROXIMAL FRACTURE WAS IMAGED. THE DISTAL FRACTURE WAS IMAGED. THE CORE WIRE WAS KINKED AT 3CM PROXIMAL TO THE FRACTURE POINT. THE CORE WIRE WAS KINKED AT 1.5CM DISTAL TO THE FRACTURE POINT. DURING FUNCTIONAL TEST, THE RETRIEVER SHAPED SECTION WAS FOUND WITHIN THE RETURNED CATHETER. 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 ¿RETRIEVER CORE WIRE BROKEN DURING USE' AND ¿DIFFICULT/UNABLE TO WITHDRAW RETRIEVER¿ WERE CONFIRMED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER THE STENT WAS BROKEN OFF WHILE RETRIEVING THE THROMBUS. THE BROKEN STENT WAS RETRIEVED WITH A SNARE. THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. THE DEVICE WAS RETURNED FOR INVESTIGATION, AND THE CORE WIRE WAS SEEN TO BE KINKED/BEND AND BROKEN. THE RETRIEVER SHAPED SECTION WAS FOUND WITHIN THE RETURNED CATHETER. SEM (SCANNING ELECTRON MICROSCOPE) IMAGING WAS PERFORMED ON THE FRACTURE POINT SHOWING EVIDENCE OF DUCTILE OVERLOAD FAILURE UNDER BENDING AND TENSION. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED ¿RETRIEVER CORE WIRE BROKEN DURING USE¿ AND ¿DIFFICULT/UNABLE TO WITHDRAW RETRIEVER¿ AND AS ANALYZED ¿RETRIEVER CORE WIRE KINKED¿ AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.
IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE FOR M1 CEREBRAL INFARCTION IN A PATIENT, THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS WITHDRAWN FROM THE PATIENT ANATOMY AND THE SUBJECT STENT CORE WIRE BROKE OFF WHILE RETRIEVING THE THROMBUS WITH ASPIRATION CATHETER. THE BROKEN SUBJECT STENT WAS RETRIEVED WITH A SNARE. RECANALIZATION COULD NOT BE OBTAINED; THE PROCEDURE WAS COMPLETED AS IT WAS. ALTHOUGH THE INFARCTED NEST HAS SPREAD, IT WAS NOT CAUSED BY A PRODUCT DEFECT.
IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE FOR M1 CEREBRAL INFARCTION IN A PATIENT, THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS WITHDRAWN FROM THE PATIENT ANATOMY AND THE SUBJECT STENT CORE WIRE BROKE OFF WHILE RETRIEVING THE THROMBUS WITH ASPIRATION CATHETER. THE BROKEN SUBJECT STENT WAS RETRIEVED WITH A SNARE. RECANALIZATION COULD NOT BE OBTAINED; THE PROCEDURE WAS COMPLETED AS IT WAS. ALTHOUGH THE INFARCTED NEST HAS SPREAD, IT WAS NOT CAUSED BY A PRODUCT DEFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 966263 | TREVO NXT 6MM X 37MM - US | NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT | POL | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY | 90315 | 0000069865 | 07613327299953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| O | VECTA 71 ASPIRATION CATHETER (STRYKER). |