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	Component Missing (2306)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the subject device was hard to see under flourscopy.There were no clinical consequences reported due to the event and the procedure was completed.No further information is available.
Additional Manufacturer Narrative
Based on the results of the dhr (device history record ) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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.As per the additional information, this is more of a complaint of it being harder to visualize vs not being visible at all.As the device was not returned and a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that the subject device was hard to see under flourscopy.There were no clinical consequences reported due to the event and the procedure was completed.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
• MDR Report Key: 10525527
• Report Number: 3012931345-2020-00138
• Device Sequence Number: 3055324
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 05/26/2022
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 0000045954
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1