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	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mechanical thrombectomy procedure was performed for acute cerebral ischemia, in left middle cranial artery distal occlusion in a patient.During the procedure, recanalization could not be obtained in the first pass using the subject retriever stent, thus a second pass was made with the subject retriever stent.The subject stent got prematurely deployed between m2 and m1 during the second pass.The operator attempted to retrieve the subject retriever stent by aspirating it through the back lock syringe, without removing the microcatheter.The operator was able to retrieve only the subject retriever stent delivery wire out, leaving the subject retriever stent inside the patient's vascular anatomy as the subject stent was fractured at the junction between the stent and the delivery wire.No clinical consequences were reported to the patient due to this event (confirmed on (b)(6) 2021 by the doctor).No further information is available on the current condition of the patient.
Event or Problem Description
It was reported that a mechanical thrombectomy procedure was performed for acute cerebral ischemia, in left middle cranial artery distal occlusion in a patient.During the procedure, recanalization could not be obtained in the first pass using the subject retriever stent, thus a second pass was made with the subject retriever stent.The subject stent got prematurely deployed between m2 and m1 during the second pass.The operator attempted to retrieve the subject retriever stent by aspirating it through the back lock syringe, without removing the microcatheter.The operator was able to retrieve only the subject retriever stent delivery wire out, leaving the subject retriever stent inside the patient's vascular anatomy as the subject stent was fractured at the junction between the stent and the delivery wire.No clinical consequences were reported to the patient due to this event (confirmed on (b)(6), 2021 by the doctor).No further information is available on the current condition of the patient.
Additional Manufacturer Narrative
H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 expiration date - added.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.Visual/microscopic inspection: the retriever shaped section was detached and not returned.The insertion tool was not returned.The core wire was kinked.The retriever core wire was broken and the pebax was damaged.Functional test: unable to carry out due to condition of returned device.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.The device was returned and it was confirmed that the retriever core wire was fractured.It is probable that there were procedural and/or anatomical factors present during the clinical procedure which caused the retriever core wire to fracture during the attempt to remove from the patient.Nc# (b)(4) was opened for increase in retriever core wire fracture complaints.This event is being addressed via capa# 2878186.An assignable cause of 'procedural factors' will be assigned to the as reported 'un-retrieved device fragments' and the as reported/as analyzed 'retriever core wire broken during use' and the analyzed 'retriever delivery wire lamination damage/peeling', and 'retriever core wire kinked' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• 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
• 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: 12837227
• Report Number: 3012931345-2021-00187
• Device Sequence Number: 4529029
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 02/21/2023
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 59173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 02/20/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• 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 6 INTERMEDIATE CATHETER (STRYKER).; TREVO TRAK 21 MICROCATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown