MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 4MM X 41MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Model Number	90314
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that follow up angiogram taken post procedure, where a retriever (subject device) was used, showed vessel extravasation.Patient suffered a reperfusion hemorrhage post procedure and the ruptured vessel was embolized with liquid embolic agent.It was reported that the patient's health prognosis is dire.No other clinical consequences were reported to the patient due to this event.
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 as well as physical analysis cannot be performed.The reported event could not be confirmed and it cannot be confirmed if the device met specification, as the device 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.Physician does not want to be contacted.No additional information available regarding whether device prepared for use as per the directions for use, or if damage noted to the packaging prior to opening the packaging, or if device was 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 this complaint.
Event or Problem Description
It was reported that follow up angiogram taken post procedure, where a retriever (subject device) was used, showed vessel extravasation.Patient suffered a reperfusion hemorrhage post procedure and the ruptured vessel was embolized with liquid embolic agent.It was reported that the patient's health prognosis is dire.No other clinical consequences were reported to the patient due to this event.

• Brand Name: TREVO NXT 4MM X 41MM - 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: 11256753
• Report Number: 3012931345-2021-00025
• Device Sequence Number: 14399369
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 04/07/2021

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: 10/14/2022
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 0000053092
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 01/31/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR