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	07/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed because the lot number remains unknown, however 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu.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.Device is not available to manufacturer.
Event or Problem Description
It was reported that a thrombectomy was performed on the left m1 distal segment of the middle cerebral artery.First and second pass were performed with subject stent retriever and aspiration catheter.Vessel dissection occurred during procedure, which the physician confirmed was not related to the subject stent retriever.Imaging done five hours post procedure revealed sub arachnoid hemorrhage.No other information is available.
Event or Problem Description
It was reported that a thrombectomy was performed on the left m1 distal segment of the middle cerebral artery.First and second pass were performed with subject stent retriever and aspiration catheter.Vessel dissection occurred during procedure, which the physician confirmed was not related to the subject stent retriever.Imaging done five hours post procedure revealed sub arachnoid hemorrhage.No other information is available.Additional information was received which reported that the patient had two sub arachnoid hemorrhages after the procedure using the subject retriever.First hemorrhage occurred 5 hours post procedure and second hemorrhage occurred 13 hours post procedure.No other information is available.
Additional Manufacturer Narrative
B5 executive summary - updated.B6 relevant tests and lab data - updated.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 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu.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: 10872791
• Report Number: 3012931345-2020-00202
• Device Sequence Number: 11486932
• 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): 02/03/2021

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: 10/26/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 02/03/2021
• 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: MARKSMAN 27 CATHETER (UNKNOWN).; MARKSMAN 27 CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR