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

Model Number	90315
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the device is not available to the manufacturer.
Event or Problem Description
It was reported that during an endovascular procedure in a patient, there was difficulty to advance the subject stent retriever initially and then it broke.The procedure was completed successfully by replacing the subject device.There was a surgical delay of 5-10 minutes due to the reported issue.No clinical consequences were reported to the patient due to this event.Other information is available.
Additional Manufacturer Narrative
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 subject stent retriever was broken.As per the additional information, it was very difficult to advance the retriever, initially.The device was prepared as per the dfu, continuous flush was maintained throughout the procedure and there was no damage noted to the microcatheter and/or insertion tool prior to use.There are a number of potential causes for the reported event, however, as the device was not returned and a review of all available information fails to indicate an assignable cause, an assignable cause of undeterminable will be assigned to the reported event.
Event or Problem Description
It was reported that during an endovascular procedure in a patient, there was difficulty to advance the subject stent retriever initially and then it broke.The procedure was completed successfully by replacing the subject device.There was a surgical delay of 5-10 minutes due to the reported issue.No clinical consequences were reported to the patient due to this event.O other 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: 17068362
• Report Number: 3012931345-2023-00121
• Device Sequence Number: 14975991
• Product Code: POL
• UDI-Device Identifier: 07613327299953
• UDI-Public: 07613327299953
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K200117
• 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): 08/11/2023

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: 10/08/2024
• Device Model Number: 90315
• Device Catalogue Number: 90315
• Device Lot Number: 0000188995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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
• Patient Sex: Unknown