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); Vascular Dissection (3160)
Date of Event	01/14/2020
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 during a procedure on (b)(6) 2020 for left p2 cardiogenic cerebral embolism in which the subject retriever was used, a causative vascular dissection was observed.Following completed procedure on (b)(6) 2020, patient experienced intracranial hemorrhage ph-1 (parenchymal hematoma type 1).Patient had preoperative mrs (modified rankin scale) of grade 0 and a mrs grade of 3 dated (b)(6) 2020.No further information was provided.
Event or Problem Description
It was reported that during a procedure on (b)(6) 2020 for left p2 cardiogenic cerebral embolism in which the subject retriever was used, a causative vascular dissection was observed.Following completed procedure on (b)(6) 2020, patient experienced intracranial hemorrhage ph-1 (parenchymal hematoma type 1).Patient had preoperative mrs (modified rankin scale) of grade 0 and a mrs grade of 3 dated 26-feb-2020.No further information was 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 reported patient intracranial hemorrhage and patient vessel dissection 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 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: 10287053
• Report Number: 3012931345-2020-00102
• Device Sequence Number: 11553991
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (Y/N): N
• 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): 09/25/2020

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: 90183
• Device Catalogue Number: 90183
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/25/2020
• 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: SOFIAFLOW PLUS ASPIRATION CATHETER (UNKNOWN); SOFIAFLOW PLUS ASPIRATION CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR