MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 3MM X 32MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Model Number	90312
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	09/12/2020
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 following an acute ischemic stroke, a thrombectomy procedure using the stent retriever combination technique in the left middle cerebral artery m3 segment was performed.During the procedure, vessel reperfusion was not achieved.Perforation of blood vessels occurred which was related to the subject stent retriever.One day post procedure, the patient had symptomatic intracranial hemorrhage (ph-2 parenchymal hematoma) and subarachnoid hemorrhage (sah) which caused prolongation of existing hospitalization.Intervention performed due to these events are unknown.Relationship of ph-2 and sah to subject stent retriever and procedure are also unknown.Patient passed away 18 days post procedure.Physician confirmed that patient death was not related to subject stent retriever, procedure or primary disease.Cause of death was not provided.No other information is available.
Event or Problem Description
It was reported that following an acute ischemic stroke, a thrombectomy procedure using the stent retriever combination technique in the left middle cerebral artery m3 segment was performed.During the procedure, vessel reperfusion was not achieved.Perforation of blood vessels occurred which was related to the subject stent retriever.One day post procedure, the patient had symptomatic intracranial hemorrhage (ph-2 parenchymal hematoma) and subarachnoid hemorrhage (sah) which caused prolongation of existing hospitalization.Intervention performed due to these events are unknown.Relationship of ph-2 and sah to subject stent retriever and procedure are also unknown.Patient passed away 18 days post procedure.Physician confirmed that patient death was not related to subject stent retriever, procedure or primary disease.Cause of death was not provided.No other information is available.
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device is not available; therefore, visual and functional testing 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.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.As per the additional information the device was prepared for use as per the directions for use, no damage noted to the packaging prior to opening the packaging, and device confirmed to be in good condition during preparation/prior to use on the patient.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files, an assignable cause of patient-anticipated procedural complication will be assigned to the as reported patient intracranial hemorrhage and patient vessel perforation.

• Brand Name: TREVO NXT 3MM X 32MM - US
• Common Device Name: NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 11496204
• Report Number: 3012931345-2021-00044
• Device Sequence Number: 3971742
• Product Code: POL
• UDI-Device Identifier: 07613327299922
• UDI-Public: 07613327299922
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200117
• 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): 04/06/2021

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 Expiration Date: 04/10/2022
• Device Model Number: 90312
• Device Catalogue Number: 90312
• Device Lot Number: 0000043835
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/06/2021
• 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: PENUMBRA DISTAL DELIVERY CATHETERS (MEDTRONICS); TREVO PRO14 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 80 YR