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	Fracture (1260)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	02/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer as the fractured portioned of the subject device was left inside the patient's vasculature.
Event or Problem Description
It was reported that a combination mechanical thrombectomy procedure was performed for nihss 18 in a patient with intra cranial atherosclerotic disease in the right middle cerebral artery with calcified clot.During the first pass mild resistance was felt in the proximal supraclinoid while advancing the subject retriever stent and when attempted to retrieve the subject retriever stent core wire broke.An attempt was made to retrieve the broken subject retriever stent using a snare, but it was not successful and therefore the subject retriever stent was left inside the patient¿s vascular anatomy (in the right middle cerebral artery).Follow up ct scan showed subarachnoid hemorrhage which was treated with medical management.The procedure could not be completed, and the patient was in the icu (intensive care unit) on a day we received the information.No further information is available.
Event or Problem Description
It was reported that a combination mechanical thrombectomy procedure was performed for nihss 18 in a patient with intra cranial atherosclerotic disease in the right middle cerebral artery with calcified clot.During the first pass mild resistance was felt in the proximal supraclinoid while advancing the subject retriever stent and when attempted to retrieve the subject retriever stent core wire broke.An attempt was made to retrieve the broken subject retriever stent using a snare, but it was not successful and therefore the subject retriever stent was left inside the patient¿s vascular anatomy (in the right middle cerebral artery).Follow up ct scan showed subarachnoid hemorrhage which was treated with medical management.The procedure could not be completed, and the patient was in the icu (intensive care unit) on a day we received the information.No further information is available.It was confirmed on 29-mar-2022,that the same reported event, product had already been entered under emdr (initial): core id: (b)(4) and report id: 3012931345-2022-00043.Based on this update, pi# (b)(4) for which emdr (initial): core id: (b)(4) and report id: 3012931345-2022-00041 was filed will be cancelled due this duplicate entry.Refer to pi# (b)(4)/ emdr (initial): core id: (b)(4) and report id: 3012931345-2022-00043 for the continuation of the complaint process of the alleged issue associated with the subject complaint device.
Additional Manufacturer Narrative
B5 executive summary - updated (pi# (b)(4) for which emdr (initial): core id: (b)(4) and report id: 3012931345-2022-00041 was filed will be cancelled due this duplicate entry).

• 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: 13663681
• Report Number: 3012931345-2022-00041
• Device Sequence Number: 5295295
• Product Code: POL
• UDI-Device Identifier: 07613327299953
• UDI-Public: 07613327299953
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/08/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 90315
• Device Catalogue Number: 90315
• Device Lot Number: 0000050893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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: INFINITY LONG SHEATH ( STRYKER); RED72 ASPIRATION CATHETER (PENUMBRA, INC); VELOCITY MICROCATHETER (PENUMBRA, INC)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Unknown
• Patient Weight: 61 KG