MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90182
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on 28-april-2020 indicated that vasospasm occurred and requiring medication during use of the subject device (retriever); therefore, the event meets reporting criteria with the awareness date of 28-april-2020.This is a third report.The subject device is unavailable to manufacturer.
Event or Problem Description
Additional information received on 28-april-2020 indicated that vasospasm occurred and requiring medication during use of the subject device (retriever).The medication was administered, and the outcome of the adverse event was resolved.According to the site, the relationship of the vasospasm to the subject device (retriever), the distal access catheter, the balloon catheter and to the procedure.No other information was provided.
Event or Problem Description
Additional information received on (b)(6) 2020 indicated that vasospasm occurred and requiring medication during use of the subject device (retriever).The medication was administered, and the outcome of the adverse event was resolved.According to the site, the relationship of the vasospasm to the subject device (retriever), the distal access catheter, the balloon catheter and to the procedure.No other information was provided.
Additional Manufacturer Narrative
The device history record review confirms 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.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.Therefore, a probable cause of anticipated procedural complication will be assigned to this event.

• Brand Name: TREVO XP PROVUE 4MM 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: 10023196
• Report Number: 3012931345-2020-00070
• Device Sequence Number: 2937288
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• PMA/510(K) Number: K132641
• 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): 06/01/2020

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 Expiration Date: 06/05/2021
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: 200108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 06/01/2020
• 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: AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER); FLOWGATE2 BALLOON GUIDE CATHETER (STRYKER); AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER); FLOWGATE2 BALLOON GUIDE CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR