TREVO XP PROVUE 4MM X 20MM
Report
- Report Number
- 3012931345-2020-00207
- Event Type
- Injury
- Date Received
- December 1, 2020
- Date of Event
- October 30, 2020
- Report Date
- July 27, 2021
- Manufacturer
- STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
- Product Code
- NRY
- UDI-DI
- 00815742001822
- PMA / PMN Number
- K132641
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- Reporter Occupation
- PHYSICIAN
Narratives
H3 DEVICE EVALUATED BY MFG ¿UPDATED. H3 SUMMARY ATTACHED - UPDATED. BASED ON THE RESULTS OF THE DHR REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. DURING VISUAL INSPECTION, THE TREVO RETRIEVER WAS RETURNED WITH AN XT-27 MICROCATHETER AND AN UNKNOWN GUIDEWIRE. THE RETRIEVER PUSHER WAS RETURNED, THE DISTAL END WAS FOUND FRACTURED AND THE SHAPED SECTION WAS NOT ATTACHED TO THE CORE WIRE. THE PROXIMAL COIL WAS NOT ATTACHED TO THE CORE WIRE AND WAS CONTAINED WITHIN THE RETURNED XT-27 MICROCATHETER. THE MICROCATHETER WAS FLUSHED AND THE PROXIMAL COIL WAS REMOVED, IT WAS SEVERELY STRETCHED. THE XT-27 MICROCATHETER WAS NOTED TO BE EXTENSIVELY DEFORMED ALONG ITS ENTIRE LENGTH AND STRETCHED TO THE DISTAL END. BASED ON SEM IMAGING OF THE DEVICE AND REPORTED "FRACTURE" AREA, IT WAS FOUND THAT NO FRACTURE HAD OCCURRED ON THE CORE WIRE ITSELF. THERE WAS EVIDENCE OF A SEPARATION OF THE DEVICE FROM AT THE MSJ (MID SOLDER JUNCTION). A FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICES. 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 DEVICE WAS RETURNED AND IT WAS NOTED THAT THE RETRIEVER SHAPED SECTION HAD SEPARATED FROM THE CORE WIRE, THE RETRIEVER WAS UNABLE TO RETRIEVED FROM THE PATIENT ANATOMY CAUSING STROKE. THERE WAS AN XT-27 MICROCATHETER RETURNED WITH THE DEVICE WHICH WAS NOTED TO BE EXTENSIVELY DEFORMED AND STRETCHED. IT IS LIKELY THAT THE MICROCATHETER WAS DAMAGED DURING THE CLINICAL PROCEDURE PREVENTING THE TREVO RETRIEVER FROM BEING REMOVED AND THE SUBSEQUENT SEPARATION OF THE RETRIEVER DURING THE ATTEMPT TO RETRIEVE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WAS ASSIGNED TO THE AS REPORTED ISSUES DIFFICULT/UNABLE TO WITHDRAW RETRIEVER, UN-RETRIEVED DEVICE FRAGMENTS, RETRIEVER FRACTURE/BROKEN DURING USE AND PATIENT STROKE AND TO THE ANALYZED ISSUES RETRIEVER CORE WIRE BROKEN DURING USE AND RETRIEVER COILS DAMAGED, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.
BASED ON THE RESULTS OF THE DHR REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. DURING VISUAL INSPECTION, THE TREVO RETRIEVER WAS RETURNED WITH AN XT-27 MICROCATHETER AND AN UNKNOWN GUIDEWIRE. THE RETRIEVER PUSHER WAS RETURNED, THE DISTAL END WAS SEPARATED FROM THE MSJ (MID SOLDER JUNCTION), AND THE SHAPED SECTION WAS NOT ATTACHED TO THE CORE WIRE. THE PROXIMAL COIL WAS NOT ATTACHED TO THE CORE WIRE. THE PROXIMAL COIL WAS NOTED TO BE CONTAINED WITHIN THE RETURNED XT-27 MICROCATHETER. THE MICROCATHETER WAS FLUSHED AND THE PROXIMAL COIL WAS REMOVED, IT WAS SEVERELY STARCHED AND EXTENSIVELY DEFORMED ALONG ITS ENTIRE LENGTH TO THE DISTAL END. BASED ON SEM IMAGING OF THE DEVICE AND REPORTED "FRACTURE" AREA, IT WAS FOUND THAT NO FRACTURE HAD OCCURRED ON THE CORE WIRE ITSELF. THERE WAS EVIDENCE OF A SEPARATION OF THE DEVICE FROM AT THE MSJ (MID SOLDER JUNCTION). DURING FUNCTIONAL WAS UNABLE TO BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICES. 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 DEVICE WAS RETURNED AND IT WAS NOTED THAT THE RETRIEVER SHAPED SECTION HAD SEPARATED FROM THE CORE WIRE, THE RETRIEVER WAS UNABLE TO BE RETRIEVED FROM THE PATIENT CAUSING STROKE. THERE WAS AN XT-27 MICROCATHETER RETURNED WITH THE DEVICE WHICH WAS NOTED TO BE EXTENSIVELY DEFORMED AND STRETCHED. IT IS LIKELY THAT THE XT-27 MICROCATHETER WAS DAMAGED DURING THE CLINICAL PROCEDURE PREVENTING THE TREVO RETRIEVER FROM BEING REMOVED AND THE SUBSEQUENT SEPARATION OF THE RETRIEVER DURING THE ATTEMPT TO RETRIEVE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WAS ASSIGNED TO THE REPORTED ISSUES DIFFICULT/UNABLE TO WITHDRAW RETRIEVER, UN-RETRIEVED DEVICE FRAGMENTS, RETRIEVER FRACTURE/BROKEN DURING USE AND PATIENT STROKE AND TO THE ANALYZED ISSUES RETRIEVER FRACTURE/BROKEN DURING USE AND RETRIEVER COILS DAMAGED, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.
THE PATIENT PRESENTED TO THE HOSPITAL WITH A CLOT ON THE SUPERIOR DIVISION OF THE RIGHT MIDDLE CEREBRAL ARTERY (DISTAL M1 SEGMENT). DURING THE FIRST ATTEMPT USING THE RETRIEVER, THE SUBJECT RETRIEVER WAS STUCK WHEN THE PHYSICIAN TRIED TO PULL IT OUT AND WAS NOTED TO BE BROKEN. THE PHYSICIAN WAS NOT ABLE TO REMOVE ALL PARTS OF THE BROKEN RETRIEVER. THE DETACHED PART OF THE RETRIEVER WAS LEFT IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. POST PROCEDURE, THE PATIENT SUFFERED FROM HEMISPHERIC STROKE ON THE RIGHT.
THE PATIENT PRESENTED TO THE HOSPITAL WITH A CLOT ON THE SUPERIOR DIVISION OF THE RIGHT MIDDLE CEREBRAL ARTERY (DISTAL M1 SEGMENT). DURING THE FIRST ATTEMPT USING THE RETRIEVER, THE SUBJECT RETRIEVER WAS STUCK WHEN THE PHYSICIAN TRIED TO PULL IT OUT AND WAS NOTED TO BE BROKEN. THE PHYSICIAN WAS NOT ABLE TO REMOVE ALL PARTS OF THE BROKEN RETRIEVER. THE DETACHED PART OF THE RETRIEVER WAS LEFT IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. POST PROCEDURE, THE PATIENT SUFFERED FROM HEMISPHERIC STROKE ON THE RIGHT.
THE PATIENT PRESENTED TO THE HOSPITAL WITH A CLOT ON THE SUPERIOR DIVISION OF THE RIGHT MIDDLE CEREBRAL ARTERY (DISTAL M1 SEGMENT). DURING THE FIRST ATTEMPT USING THE RETRIEVER, THE SUBJECT RETRIEVER WAS STUCK WHEN THE PHYSICIAN TRIED TO PULL IT OUT AND WAS NOTED TO BE BROKEN. THE PHYSICIAN WAS NOT ABLE TO REMOVE ALL PARTS OF THE BROKEN RETRIEVER. THE DETACHED PART OF THE RETRIEVER WAS LEFT IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. POST PROCEDURE, THE PATIENT SUFFERED FROM HEMISPHERIC STROKE ON THE RIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1392973 | TREVO XP PROVUE 4MM X 20MM | CATHETER, THROMBUS RETRIEVER | NRY | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY | 90182 | 0000022639 | 00815742001822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Other | EXCELSIOR XT- 27 MICROCATHETER (STRYKER)| EXCELSIOR XT- 27 MICROCATHETER (STRYKER) |