MAUDE Adverse Event Report: STRYKER CORPORATION TREVO NXT; CATHETER, THROMBUS RETRIEVER

Model Number	90312
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The trevo device was difficult to remove from the sheath after use.Upon inspection after removal, the device was crushed and mangled and dr.[redacted] asked for a new one.

• Brand Name: TREVO NXT
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 23553772
• Report Number: 23553772
• Device Sequence Number: 9449152
• Product Code: NRY
• UDI-Device Identifier: 07613327299922
• UDI-Public: (01)07613327299922
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/16/2025
• Report Date (Section F): 10/20/2025

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 Model Number: 90312
• Device Catalogue Number: 90312
• Device Lot Number: 0000828913
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 11/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Date Report Sent to FDA: 10/20/2025