MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 4MM X 41MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Model Number	90314
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thrombectomy procedure in a truncated occluded right middle cerebral artery, the subject retriever fractured at the junction and was unable to be removed from the patient anatomy.Patient anatomy was not tortuous and resistance during the procedure was not reported.The physician tried to remove the fragment for two hours with a snare and additional stent retriever which was deployed distally to try and latch but was not successful.Patient was reported to be alive and additional imaging was required to determine if additional medication would be given due to this event.The clot was partially removed and perfusion score of thrombolysis in cerebral infarction (tici) 2b was achieved.No other information is available.
Event or Problem Description
It was reported that during a thrombectomy procedure in a truncated occluded right middle cerebral artery, the subject retriever fractured at the junction and was unable to be removed from the patient anatomy.Patient anatomy was not tortuous and resistance during the procedure was not reported.The physician tried to remove the fragment for two hours with a snare and additional stent retriever which was deployed distally to try and latch but was not successful.Patient was reported to be alive and additional imaging was required to determine if additional medication would be given due to this event.The clot was partially removed and perfusion score of thrombolysis in cerebral infarction (tici) 2b was achieved.No other information is available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The reported lot number was confirmed from the returned packaging.The device was returned without the insertion tool and catheter that was used.The reported lot number was confirmed from the returned packaging.On visual inspection, after decontamination the trevo nxt retriever device was examined and it was observed that the trevo nxt retriever was fractured.The trevo nxt retriever stent section (distal fragment) was left in patient.The rest of the device was found outside of the sofia within the packaging.The trevo nxt retriever core wire and proximal shaft coil were examined.Damage was seen on the pebax laminate/jacket near the core wire fracture site.The core wire was broken.The fracture occurred distal to the round-to-flat core wire transition region, but proximal to the stent (near msj, mid solder junction).Performance testing was not performed due to the condition the device was received.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.It is probable that there were procedural and/or anatomical factors present during the clinical procedure which caused the retriever core wire to fracture during the attempt to remove from the patient.An assignable cause of 'procedural factors' will be assigned to the as reported and as analyzed code 'retriever core wire broken during use and the analyzed 'retriever delivery wire lamination damage/peeling', and 'retriever core wire kinked' 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.

• Brand Name: TREVO NXT 4MM X 41MM - US
• Common Device Name: NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10947273
• Report Number: 3012931345-2020-00211
• Device Sequence Number: 19630633
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K200117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2022
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 0000044937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 11/08/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY 21 CATHETER (UNKNOWN); HEADWAY 21 CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR