MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 6MM X 37MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Catalog Number	90315
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during large vessel occlusion lvo procedure, when the subject stent retriever was retracted, the retriever became detached from the wire.There was a surgical delay of 10min due to the reported event.No additional information is available.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) 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 doctor removed the wire with the stent retriever, the subject device become detached from the wire.As per the additional information, there was a surgical delay of 10 minutes, the stent fracture occurred during retrieval.The device was not returned for analysis, and a review of all available information fails to indicate an assignable cause for the reported event, therefore an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during large vessel occlusion lvo procedure, when the subject stent retriever was retracted, the retriever became detached from the wire.There was a surgical delay of 10min due to the reported event.No additional information is available.

• Brand Name: TREVO NXT 6MM X 37MM - 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 21509450
• Report Number: 3012931345-2025-00047
• Device Sequence Number: 17243366
• Product Code: POL
• UDI-Device Identifier: 07613327299953
• UDI-Public: (01)07613327299953(17)260515(10)0000664633
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K223305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2026
• Device Catalogue Number: 90315
• Device Lot Number: 0000664633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRAK 21 MICROCATHETER (STRYKER).; ZOOM 71 CATHETER (NON-STRYKER).; ZOOM 88 CATHETER (NON-STRYKER).
• Patient Age: 82 YR
• Patient Sex: Female