MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER

Model Number	90186
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	03/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that thrombectomy procedure for the left m1-proximal, left m2 and left m3 were performed on (b)(6) 2020 using the subject retriever and the final tici score was 2b.There were no vessel preformation and vessel dissection related to the subject retriever.24 hours post follow up mir showed subarachnoid hemorrhage (sah) and intracerebral hemorrhage (ich).No clinical consequences were not reported.No other information was provided.
Event or Problem Description
It was reported that thrombectomy procedure for the left m1-proximal, left m2 and left m3 were performed on (b)(6) 2020 using the subject retriever and the final tici score was 2b.There were no vessel preformation and vessel dissection related to the subject retriever.24 hours post follow up mir showed subarachnoid hemorrhage (sah) and intracerebral hemorrhage (ich).No clinical consequences were not reported.No other information was provided.
Additional Manufacturer Narrative
B2 outcomes attributed to ae - corrected.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.Visual and functional testing could not be performed since the device was not returned for investigation.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 issue patient intracranial hemorrhage 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, an assignable cause of anticipated procedural complication will be assigned to this event.

• Brand Name: TREVO XP PROVUE 6MM X 25MM
• 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: 10723687
• Report Number: 3012931345-2020-00162
• Device Sequence Number: 3006499
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143077
• 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): 12/13/2020

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: 90186
• Device Catalogue Number: 90186
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/13/2020
• 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); ASPIRATION CATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR