MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 30MM; CATHETER, THROMBUS RETRIEVER

Model Number	90185
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that vessel dissection occurred when a retriever (subject device) was used during the procedure.Diagnostic imaging performed 19 hours post procedure show development of intracerebral hemorrhage (ich).It was reported that the patient's mrs score was 5.The procedure was completed successfully.No further clinical consequences were reported to the patient due to this event at the moment.
Event or Problem Description
It was reported that vessel dissection occurred when a retriever (subject device) was used during the procedure.Diagnostic imaging performed 19 hours post procedure show development of intracerebral hemorrhage (ich).It was reported that the patient's mrs score was 5.The procedure was completed successfully.No further clinical consequences were reported to the patient due to this event at the moment.
Additional Manufacturer Narrative
Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.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.It was reported that vessel dissection occurred when the subject retriever was used during the procedure.Diagnostic imaging performed 19 hours post procedure showed development of intracerebral hemorrhage (ich).Additional information provided by the customer indicated that the mrs score became worse post procedure from 3 to 5.There was no vessel perforation or device malfunction during the procedure.The reported events are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.However, in the case of this complaint, the cause of these adverse events and their relation to the subject device could not be definitively determined.Therefore, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: TREVO XP PROVUE 4MM X 30MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10841624
• Report Number: 3012931345-2020-00195
• Device Sequence Number: 11519329
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150616
• 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): 01/05/2021

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 Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 11/15/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRATION CATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 86 YR