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	10/14/2020
Type of Reportable Event	Serious Injury
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 available; therefore, a visual inspection as well as a functional evaluation could not 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 states "vessel perforation, which was allegedly not related to trevo, occurred during procedure.There were no other patient injury such as vessel dissection or device malfunction during procedure.Ct follow-up 16.5 hours after the procedure on oct 15th revealed ich(hi-1)." the reported 'patient vessel perforation' and 'patient intracranial hemorrhage' are 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.
Event or Problem Description
During thrombectomy procedure, the subject retriever along with other devices were used to remove the clot from left m2 lesion.Pre procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 13 and mrs (modified rankin score) of 0.Aspects before procedure was 10.The tici was improved to 2b after the first pass.However, the vessel perforation occurred during the procedure which was allegedly not related to the subject retriever.There was no other patient injury such as vessel dissection or device malfunction during procedure.24 hours post procedure computer tomography (ct) confirmed the intracranial hemorrhage (ich).7 days post procedure, the nihss of 17 and the mrs score became worse to 4.The mrs score of 4 was reconfirmed post 50 days procedure.The physician stated that patient's m2 infarction was "cardio embolism" according to toast classification.No other information was provided.

• 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: 11078401
• Report Number: 3012931345-2020-00228
• Device Sequence Number: 3310826
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/28/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/28/2020
• 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: ASPIRATION CATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR