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

Catalog Number	90314
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the subject stent retriever got stuck in the internal carotid artery and a carotid-cavernous fistula was created.No further information is available.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject stent retriever was not returned for analysis; therefore, physical as well as a functional testing could not be performed.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 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 stuck within the internal carotid artery (ica) and a carotid-cavernous fistula (ccf) formed.Additional information provided by the customer indicated that no anomalies were noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu, the microcatheter was flushed before the retriever was inserted, continuous flush was maintained throughout the procedure, the anatomy was not tortuous, and force was applied to overcome resistance to advance or withdraw the retriever.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the subject stent retriever was not returned for analysis, an assignable cause of undeterminable was assigned to the as reported code difficult/unable to withdraw retriever.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.The as reported code patient av fistula is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that during the procedure, the subject stent retriever got stuck in the internal carotid artery and a carotid-cavernous fistula was created.No further information is available.

• 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: 19578411
• Report Number: 3012931345-2024-00104
• Device Sequence Number: 12885074
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2026
• Device Catalogue Number: 90314
• Device Lot Number: 0000623555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown