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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the thrombectomy of internal carotid artery (ica) occlusion, a second approach was performed due to residual thrombus.The stent deployment proceeded without issue, but during retrieval, despite pulling the entire system, the subject stent delivery wire became fractured, leaving the subject stent and part of the wire in the body.Subsequently, attempts were made to retrieve the remaining devices using a stent retriever and snare device, but these proved unsuccessful.Therefore, treatment was concluded with the devices remaining inside the patient's body.The patient's adl was already poor, and the impact of this event is unclear.
Event or Problem Description
It was reported that during the thrombectomy of internal carotid artery (ica) occlusion, a second approach was performed due to residual thrombus.The stent deployment proceeded without issue, but during retrieval, despite pulling the entire system, the subject stent delivery wire became fractured, leaving the subject stent and part of the wire in the body.Subsequently, attempts were made to retrieve the remaining devices using a stent retriever and snare device, but these proved unsuccessful.Therefore, treatment was concluded with the devices remaining inside the patient's body.The patient's adl was already poor, and the impact of this event is unclear.
Additional Manufacturer Narrative
D9 product available to stryker: updated.D9 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject core wire was confirmed to have been fractured.There was evidence of necking/stretching noted to the lamination and the core wire.The distal section of the core wire and retriever were not returned.A functional test could not be performed as the core wire had been fractured.The reported event is covered in the device direction 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 core wire fracture was confirmed based on the device analysis.The reported retriever difficult/unable to go through catheter shaft was unable to be replicated during analysis as the distal end of the retriever was not returned.The analysis results are consistent with the reported event.The device failed to meet specifications when received, based on the damage noted.It was reported that the 1st pass had no issue using the subject stent retriever.A second approach was performed due to residual thrombus.The subject stent deployment proceeded without issue, but during retrieval, despite pulling the entire system, the stent delivery wire became fractured, leaving the stent and part of the wire remained in the body.Subsequently, attempts were made to retrieve the remaining devices using a stent retriever and snare device, but these proved unsuccessful.As per the additional information, it is unknown if any force was applied against the resistance, torque was not applied when retrieving the device from the blood vessel, the microcatheter distal tip marker was maintained at the proximal end of the stent during manipulation or removal, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was of average tortuosity.The device was returned, and it was confirmed that the retriever core wire had been fractured, there was also damage noted to the lamination at the fracture location.It is probable that there were procedural and/or anatomical factors present during the clinical procedure which caused the difficulty to advance the retriever through the catheter and the subsequent retriever core wire fracture.An assignable cause of procedural factors will be assigned to the reported event retriever core wire broken during use and un-retrieved device fragments and to the analyzed defects retriever core wire broken/fractured during use and retriever delivery wire lamination issue, 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 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: 23151656
• Report Number: 3012931345-2025-00163
• Device Sequence Number: 15991044
• Product Code: POL
• UDI-Device Identifier: 07613327299953
• UDI-Public: (01)07613327299953(17)270121(10)0000780917
• 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): 12/16/2025

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: 0000780917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SNARE (UNKNOWN).; STENT RETRIEVER (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown