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	Vascular Dissection (3160)
Date of Event	08/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that the subject retriever was used during thrombectomy procedure for a clot in the left m2 branch on (b)(6) 2020 and vessel dissection occurred related to the subject retriever.2 passes were performed using the subject retriever and 1 pass was performed using non-stryker retriever.The final tici (thrombolysis in cerebral infarction score) of 2b.Hemorrhage was not observed in the mir scan 24 hours post procedure.There were no clinical consequences reported due to this event.No additional information was provided.
Additional Manufacturer Narrative
F10 / h6 : component code - corrected.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.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.Additional information provided by the customer indicated that the devices performed as intended.The reported issue patient vessel dissection 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, an assignable cause of anticipated procedural complication will be assigned to this event.
Event or Problem Description
It was reported that the subject retriever was used during thrombectomy procedure for a clot in the left m2 branch on (b)(6) 2020 and vessel dissection occurred related to the subject retriever.2 passes were performed using the subject retriever and 1 pass was performed using non-stryker retriever.The final tici (thrombolysis in cerebral infarction score) of 2b.Hemorrhage was not observed in the mir scan 24 hours post procedure.There were no clinical consequences reported due to this event.No additional information was provided.

• 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: 10636856
• Report Number: 3012931345-2020-00153
• Device Sequence Number: 11372388
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/22/2020

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: 90182
• Device Catalogue Number: 90182
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: RETRIEVER (UNKNOWN MANUFACTURER); RETRIEVER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Other