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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the thrombectomy procedure for m1 cerebral infarction in a patient, there was resistance when the subject stent retriever was withdrawn from the patient anatomy and the subject stent core wire broke off while retrieving the thrombus with aspiration catheter.The broken subject stent was retrieved with a snare.Recanalization could not be obtained; the procedure was completed as it was.Although the infarcted nest has spread, it was not caused by a product defect.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the retriever shaped section was noted to have been broken/fractured from the core wire at 9.5 cm from the msj (mid solder joint) to pebax transition.The proximal fracture was imaged.The distal fracture was imaged.The core wire was kinked at 3cm proximal to the fracture point.The core wire was kinked at 1.5cm distal to the fracture point.During functional test, the retriever shaped section was found within the returned catheter.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 reported ¿retriever core wire broken during use' and ¿difficult/unable to withdraw retriever¿ were confirmed.Additional information provided by the customer the stent was broken off while retrieving the thrombus.The broken stent was retrieved with a snare.That the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure.The device was returned for investigation, and the core wire was seen to be kinked/bend and broken.The retriever shaped section was found within the returned catheter.Sem (scanning electron microscope) imaging was performed on the fracture point showing evidence of ductile overload failure under bending and tension.An assignable cause of procedural factors will be assigned to the as reported ¿retriever core wire broken during use¿ and ¿difficult/unable to withdraw retriever¿ and as analyzed ¿retriever core wire kinked¿ as the issue is associated with a product that meets stryker design and manufacture specifications but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the thrombectomy procedure for m1 cerebral infarction in a patient, there was resistance when the subject stent retriever was withdrawn from the patient anatomy and the subject stent core wire broke off while retrieving the thrombus with aspiration catheter.The broken subject stent was retrieved with a snare.Recanalization could not be obtained; the procedure was completed as it was.Although the infarcted nest has spread, it was not caused by a product defect.

• 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: 16815493
• Report Number: 3012931345-2023-00073
• Device Sequence Number: 17523626
• 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): 07/26/2023

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: 08/01/2023
• Device Model Number: 90315
• Device Catalogue Number: 90315
• Device Lot Number: 0000069865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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: VECTA 71 ASPIRATION CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown