MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 3MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90183
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
Date of Event	05/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that thrombectomy procedure for right m2 on (b)(6) 2020 subject retriever and aspiration catheter was used for two passes.Vessel perforation not related to subject retriever occurred during the procedure.Ct scan follow-up after procedure showed sah (subarachnoid hemorrhage).Patient mrs (modified rankin scale) before onset was 0.The pre-procedure tici (thrombolysis in cerebral infarction) score was 0 and final tici was 2b.Pre-procedure nihss (national institutes of health stroke scale) score was noted at 15 and final nihss was 15.No further information provided.
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 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.The event description states ¿vessel perforation not related to trevo occurred during procedure.There were no device malfunctions." the reported patient vessel perforation and 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.
Event or Problem Description
It was reported that thrombectomy procedure for right m2 on (b)(6) 2020 subject retriever and aspiration catheter was used for two passes.Vessel perforation not related to subject retriever occurred during the procedure.Ct scan follow-up after procedure showed sah (subarachnoid hemorrhage).Patient mrs (modified rankin scale) before onset was 0.The pre-procedure tici (thrombolysis in cerebral infarction) score was 0 and final tici was 2b.Pre-procedure nihss (national institutes of health stroke scale) score was noted at 15 and final nihss was 15.No further information provided.

• Brand Name: TREVO XP PROVUE 3MM X 20MM
• 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: 10849233
• Report Number: 3012931345-2020-00197
• Device Sequence Number: 11367515
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133464
• 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): 01/07/2021

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: 90183
• Device Catalogue Number: 90183
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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); ASPIRATION CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR