MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER

Model Number	90186
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Vascular Dissection (3160)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during thrombectomy for right cervical- ica (internal carotid artery) was performed on patient with modified ranking scale: mrs score: 3 (scale +3: moderate disability; requiring some help, but able to walk without assistance) and alberta stroke program early ct score: aspects before procedure was (b)(6) 2020.First pass and second pass were performed with retriever (subject device) and aspiration catheter.However, thrombolysis in cerebral infarction scale: tici was still 0: no perfusion after 2 pass.In addition, vessel dissection occurred during procedure, which was allegedly related to retriever.There were no vessel perforation, or device malfunction during procedure.Mri follow-up 12.5 hours after the procedure on (b)(6) 2020 revealed ich (intracranial hemorrhage).Modified ranking scale: mrs score became worse to +4 (moderately severe disability; unable to walk and attend to bodily needs without assistance) though national institutes of health stroke scale: nihss was changed from 14 to 13 on oct 26th, 2020.It was reported that the procedure was completed successfully and it is under confirmation why the procedure was finished though tici was 0 after 2nd pass.No other information is available.
Event or Problem Description
It was reported that during thrombectomy for right cervical-ica (internal carotid artery) was performed on patient with modified ranking scale: mrs score: 3 (scale +3: moderate disability; requiring some help, but able to walk without assistance) and alberta stroke program early ct score: aspects before procedure was 9 on (b)(6), 2020.First pass and second pass were performed with retriever (subject device) and aspiration catheter.However, thrombolysis in cerebral infarction scale: tici was still 0: no perfusion after 2 pass.In addition, vessel dissection occurred during procedure, which was allegedly related to retriever.There were no vessel perforation or device malfunction during procedure.Mri follow-up 12.5 hours after the procedure on sep 16th revealed ich (intracranial hemorrhage).Modified ranking scale: mrs score became worse to +4 (moderately severe disability; unable to walk and attend to bodily needs without assistance) though national institutes of health stroke scale: nihss was changed from 14 to 13 on (b)(6) 2020.It was reported that the procedure was completed successfully and it is under confirmation why the procedure was finished though tici was 0 after 2nd pass.No other information is available.
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 subject device is not available; therefore, functional testing as well as physical analysis cannot be 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.The event description states "thrombectomy for right cervical-ica was performed.Vessel dissection occurred during procedure, which was allegedly related to trevo.There were no vessel perforation or device malfunction during procedure.Mri follow-up 12.5 hours after the procedure on sep 16th revealed ich." the reported patient vessel dissection and patient intracranial hemorrhage 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 6MM X 25MM
• 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: 10893175
• Report Number: 3012931345-2020-00205
• Device Sequence Number: 14259900
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143077
• 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): 01/12/2021

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 Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/12/2021
• 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).; MARKSMAN27 MICROCATHETER (MEDTRONIC)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR