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	Perforation (2001)
Date of Event	11/09/2019
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 during thromebctomy procedure at right m2 segment of the middle cerebral artery(mca), vessel perforation occurred inside the patient's anatomy.Two passes were performed during the procedure, 1st pass was performed with the subject retriever in conjunction with other company's catheter and the 2nd pass was performed with unknown aspiration catheter.It is unknown at what stage vessel perforation occurred and what devices were related to the event.The physician denied relationship to the subject retriever.No further information is available.
Additional Manufacturer Narrative
Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned.Therefore, visual and functional analysis were not 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.It was reported that vessel perforation occurred during the procedure, but it is unclear whether the subject device was related to the reported event.The reported '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, a probable cause of 'anticipated procedural complication' will be assigned to this event.
Event or Problem Description
It was reported that during thromebctomy procedure at right m2 segment of the middle cerebral artery(mca), vessel perforation occurred inside the patient's anatomy.Two passes were performed during the procedure, 1st pass was performed with the subject retriever in conjunction with other company's catheter and the 2nd pass was performed with unknown aspiration catheter.It is unknown at what stage vessel perforation occurred and what devices were related to the event.The physician denied relationship to the subject retriever.No further information is available.

• 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: 9892313
• Report Number: 3012931345-2020-00050
• Device Sequence Number: 11212617
• 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): 04/06/2020

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: 03/11/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: ACE 068 REPERFUSION CATHETER (PENUMBRA)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR