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

Model Number	90184
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	05/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that thrombus migration to the new territory occurred during the procedure.No adverse consequences were reported due to this event.
Additional Manufacturer Narrative
D4 expiration date ¿ added.H4 manufacturing date ¿ added.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 reported event is a known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication will be assigned to this event.
Event or Problem Description
It was reported that thrombus migration to the new territory occurred during the procedure.No adverse consequences were reported due to this event.

• Brand Name: TREVO 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: 10783113
• Report Number: 3012931345-2020-00182
• Device Sequence Number: 4178300
• Product Code: NRY
• UDI-Device Identifier: 00815742001846
• UDI-Public: 00815742001846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/02/2021

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 Expiration Date: 12/02/2020
• Device Model Number: 90184
• Device Catalogue Number: 90184
• Device Lot Number: 0000019048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR