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	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure the subject stent retriever detached.A snare device was used to remove it from the patient's anatomy, but unsuccessfully.A surgical delay of unknown length was reported due to this event.No further information available.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not conducted due to the device was not returned.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 events were unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.Additional information indicates that the fracture occurred during retrieval.The physician reported that an excessive amount of force on retrieval was not felt and this was the first retrieval attempt.There are a number of potential causes for the retriever core wire to fracture during use, however as the device was not returned and a review of the available information fails to indicate an assignable cause for the reported event, an assignable cause of undeterminable will be assigned to the reported events: ¿retriever fractured/broken during use¿ and ¿un-retrieved device fragments¿.
Event or Problem Description
It was reported that during the procedure the subject stent retriever detached.A snare device was used to remove it from the patient's anatomy, but unsuccessfully.A surgical delay of unknown length was reported due to this event.No further information 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: 23574893
• Report Number: 3012931345-2025-00180
• Device Sequence Number: 10155436
• Product Code: POL
• UDI-Device Identifier: 07613327299953
• UDI-Public: (01)07613327299953(17)270414(10)0000817525
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K223305
• 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): 12/18/2025

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 Catalogue Number: 90315
• Device Lot Number: 0000817525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown