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 Code	Intracranial Hemorrhage (1891)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that a thrombectomy was preformed on the right proximal m1 vessel.First pass was done with the subject stent retriever and an aspiration catheter.2nd and third pass were done with non-stryker devices.There was no reported vessel perforation, vessel dissection or device malfunction during procedure.Physician successfully completed the procedure but 24 hours later, ct follow up scans showed intracerebral hemorrhage and sub arachnoid hemorrhage.Medical intervention in response to the hemorrhage is unknown.In the physician's opinion, the hemorrhage was caused by hemorrhagic infarction.The patient is reported to have passed away.No other information is available.
Event or Problem Description
It was reported that a thrombectomy was preformed on the right proximal m1 vessel.First pass was done with the subject stent retriever and an aspiration catheter.2nd and third pass were done with non-stryker devices.There was no reported vessel perforation, vessel dissection or device malfunction during procedure.Physician successfully completed the procedure but 24 hours later, ct follow up scans showed intracerebral hemorrhage and sub arachnoid hemorrhage.Medical intervention in response to the hemorrhage is unknown.In the physician's opinion, the hemorrhage was caused by hemorrhagic infarction.The patient is reported to have passed away.No other information is available.
Additional Manufacturer Narrative
Although the device history record (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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.As per the available information, there were no vessel perforation , vessel dissection and device malfunction during procedure.Computerized tomography (ct) follow-up, 24 hours after the procedure showed symptomatic intracerebral hemorrhage (sich) and symptomatic sub arachnoid hemorrhage (sah)".The reported 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: 10744674
• Report Number: 3012931345-2020-00170
• Device Sequence Number: 4086861
• 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): 12/08/2020

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: 90186
• Device Catalogue Number: 90186
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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: CATALYST 7 CATHETER (STRYKER); CATALYST 7 CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR