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); Perforation of Vessels (2135)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
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 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 subject device was not returned.Therefore, visual and function analysis were unable to be performed.The reported "patient vessel perforation" & "patient intracranial hemorrhage" are 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.The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that during the thrombectomy procedure, the patient's vessel perforated at the right middle cerebral artery(mca) inside the patient's anatomy.The medical treatment/intervention taken due to the reported event is unknown.The next day after the procedure, computed tomography scan was performed and asymptomatic intracranial hemorrhage (ich) was noted in patient.No further information is available.
Event or Problem Description
It was reported that during the thrombectomy procedure, the subject retriever caused vessel perforation at the right middle cerebral artery(mca) inside the patient's anatomy.The next day after the procedure, computed tomography scan was performed and asymptomatic intracranial hemorrhage (ich) was noted in patient.In the physician's opinion, the cause for the asymptomatic intracranial hemorrhage (ich) is unknown.There was no medical intervention reported.No further information is available.
Additional Manufacturer Narrative
B2 outcomes attributed to ae: updated.B5 executive summary: updated.D11 concomitant products grid: added.Additional information indicated that the cause for the as reported "patient vessel perforation" event was due to the subject retriever and the cause for the other as reported "patient intracranial hemorrhage" event is unknown.There were no medical intervention and surgical delay reported to this event.The additional information received did not alter the investigation.

• 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: 9803157
• Report Number: 3012931345-2020-00037
• Device Sequence Number: 642977
• 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): 03/17/2020

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: 02/13/2020
• Supplement Date Received by Manufacturer: 03/08/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 03/18/2020
• 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: MARKSMAN27 MICROCATHETER(MEDTRONIC)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR