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 Code	Vascular Dissection (3160)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that thrombectomy procedure was done at left m2 segment of the middle cerebral artery with the use of the subject stent retriever and an aspiration catheter.The patient's vessel dissection was confirmed during procedure.No further information is available.
Event or Problem Description
It was reported that thrombectomy procedure was done at left m2 segment of the middle cerebral artery with the use of the subject stent retriever and an aspiration catheter.The patient's vessel dissection was confirmed during procedure.No further information is available.Based on the additional information provided on 07/15/2020, antiplatelet drug was administered to treat the vessel dissection.The procedure was completed successfully using another device.The patient is in a sable condition.
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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 additional information provided by the customer indicated that no anomalies were noted to the device during preparation/prior to use, the device was prepared as per the dfu, continuous flush was maintained, and the device performed as intended.In the physician¿s opinion, the reported issue is due to procedure related.The reported issue 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: 10117521
• Report Number: 3012931345-2020-00084
• Device Sequence Number: 3083315
• 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): 08/04/2020

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: 06/30/2021
• Device Model Number: 90183
• Device Catalogue Number: 90183
• Device Lot Number: 0000029191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 08/04/2020
• 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); ASPIRATION CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 56 YR