MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 6MM X 37MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Model Number	90315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	01/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thrombus retrieval for an acute ic occlusion treatment, a guide catheter and a microcatheter were used to deliver the subject retriever to the target site.Thrombus was successfully removed; however, over contrast run immediately after the retrieval massive bleeding was observed in the ic.A mild atherosclerotic lesion was considered by the physician.The procedure was completed successfully.Patient¿s anatomy was normal and there was no health damages at the present, but, the patient's prognosis is likely to be poor.No additional information available.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Additional Manufacturer Narrative
The device history record (dhr) confirms that the device met all material, assembly and performance specifications.No visual or functional inspection was performed due to 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 subject stent was inserted into the microcatheter and deployed at the lesion site.After waiting for a few minutes, the stent was combined with distal access catheter and collected as a single mass.Retrieved thrombus was seen in the stent.The immediate contrast showed massive bleeding from the ic.Although a mild atherosclerotic lesion was considered, the passage of the lesion was smooth from catheter guidance to stent deployment, and the technique was considered to be flawless.Hemostasis was achieved by inflating the occlusion balloon proximal to the lesion, thereby interrupting blood flow, and waiting by for hemostasis.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.
Event or Problem Description
It was reported that during a thrombus retrieval for an acute ic occlusion treatment, a guide catheter and a microcatheter were used to deliver the subject retriever to the target site.Thrombus was successfully removed; however, over contrast run immediately after the retrieval massive bleeding was observed in the ic.A mild atherosclerotic lesion was considered by the physician.The procedure was completed successfully.Patient¿s anatomy was normal and there was no health damages at the present, but, the patient's prognosis is likely to be poor.No additional information available.

• Brand Name: TREVO NXT 6MM X 37MM - 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13654543
• Report Number: 3012931345-2022-00040
• Device Sequence Number: 5974021
• Product Code: POL
• UDI-Device Identifier: 07613327299953
• UDI-Public: 07613327299953
• 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): 05/18/2022

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: 02/11/2023
• Device Model Number: 90315
• Device Catalogue Number: 90315
• Device Lot Number: 58683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AXS CATALYST 7 CATHETER (STRYKER).; TREVO TRAK 21 MICROCATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female