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

Catalog Number	90314
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent retriever (subject device) was used in the thrombus retrieval procedure.The physician attempted to retrieve the thrombus; however, the thrombus could not be retrieved, nor the aspiration catheter could be raised to the target site due to the tortuosity.The physician attempted to pull the microcatheter with excessive force resulting in fracture to the shaped section of the stent and the distal tip of the stent delivery wire that remained intracranial.The procedure could not be completed however the patient was reported to be doing fine after the procedure.No further information available.
Additional Manufacturer Narrative
D4 ¿ expiration date ¿ added.D4 ¿ gtin ¿ updated.H4 ¿ manufacturing date - added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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 events could not be confirmed, and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that, attempted to deploy the stent at the m1 and retrieve the thrombus; nevertheless, the thrombus was not retrieved at all.Moreover, the aspiration catheter could not be raised to the lesion.Reluctantly, pulled the microcatheter with excessive force, the shaped section became torn off and the full length of the shape section and the distal tip of the stent delivery wire (sdw) remained intracranial.Additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure, the device was prepared for use as per the directions for use and the patient's anatomy was severely tortuous, describing severe tortuosity, requiring switching to a brachial approach.The carotid siphon section also exhibited approximately three loops of curvature, presenting extremely poor conditions.Furthermore, the catheter itself had become kinked, making device insertion and removal extremely difficult.The device was not returned for analysis, however based on a review of the event description and the additional information stating that the patients anatomy was severely tortuous, it is probable that the severely tortuous nature of the patients anatomy and the events around the difficulties navigating through and retracting the retriever through this anatomy, are the primary cause for the reported vents.An assignable cause of procedural factors will be assigned to the reported event of ¿retriever core wire broken during use¿, ¿retriever fracture/broken during use¿ and ¿un-retrieved device fragments¿, 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.
Event or Problem Description
It was reported that the stent retriever (subject device) was used in the thrombus retrieval procedure.The physician attempted to retrieve the thrombus; however, the thrombus could not be retrieved, nor the aspiration catheter could be raised to the target site due to the tortuosity.The physician attempted to pull the microcatheter with excessive force resulting in fracture to the shaped section of the stent and the distal tip of the stent delivery wire that remained intracranial.The procedure could not be completed however the patient was reported to be doing fine after the procedure.No further information available.

• Brand Name: TREVO NXT 4MM X 41MM - US
• Common Device Name: NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMEN
• 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: 23659461
• Report Number: 3012931345-2025-00188
• Device Sequence Number: 13292820
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: (01)07613327299946(17)261021(10)0000740136
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/02/2026

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: 90314
• Device Lot Number: 0000740136
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• 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: GUIDEWIRE (UNKNOWN).; SALVA41 ASPIRATION CATHETER (NON-STRYKER).; TREVO TRAK 21 MICROCATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown