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

Model Number	90314
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Foreign Body In Patient (2687)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during an endovascular procedure at basilar artery in a stroke patient, the subject stent retriever got stuck in the catheter and the core wire of the subject stent retriever fractured inside the patient vasculature.The fractured fragment was tried to be retrieved using a snare device but ruptured the vessel so the physician had to take down the vertebral artery with coils.It was reported that the rupture of the vessel was caused by the snare device.The patient was stable after the procedure.Patient's anatomy was very tortuous and the physician feels that this anatomy may have contributed to the reported event.
Event or Problem Description
It was reported that during an endovascular procedure at basilar artery in a stroke patient, the subject stent retriever got stuck in the catheter and the core wire of the subject stent retriever fractured inside the patient vasculature.The fractured fragment was tried to be retrieved using a snare device but ruptured the vessel so the physician had to take down the vertebral artery with coils.It was reported that the rupture of the vessel was caused by the snare device.The patient was stable after the procedure.Patient's anatomy was very tortuous and the physician feels that this anatomy may have contributed to the reported event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.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 device got stuck in the non-stryker catheter and fractured in the patient.They tried to snare and capture the device but ruptured the vessel so he had to take down the vertebral artery with coils.As per the additional information, the device was prepared as per the dfu, the anatomy was very tortuous, continuous flush was maintained throughout the procedure, resistance was encountered during the extraction of the clot.It is probable that the retriever experience difficulties in pulling the retriever/ clot back to the distal end of the non-stryker catheter, causing the distal end of the retriever to separate from its core wire, however as the device was not returned for analysis, this cannot be definitively determined, therefore an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: TREVO NXT 4MM X 41MM - 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: 17028737
• Report Number: 3012931345-2023-00106
• Device Sequence Number: 12365375
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K200117
• 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): 08/11/2023

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 Expiration Date: 12/26/2024
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 0000210830
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VELOCITY MICROCATHETER (NON STRYKER); ZOOM 71 ASPIRATION CATHETER (NON STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown