MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 4MM X 28MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Model Number	90313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the subject device retriever detached out of delivery wire.The procedure was completed successfully and one pass tici 3 was achieved.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during procedure the subject device retriever detached out of delivery wire.The procedure was completed successfully and one pass tici 3 was achieved.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Based on the results of the device history record (dhr) review, there is no indication that the device, labeling, or packaging failed to meet its specifications when released.During visual inspection, the retriever was detached from the core wire, the core wire was kinked, and the retriever coils were damaged, the retriever was detached, the catheter returned was intact.A functional test was unable to be performed due to the condition of the returned device.The reported event was confirmed during the device analysis.The device failed to meet specification when returned based on the damage noted.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 noted that the retriever shaped section had separated from the core wire, damage was noted to the retriever.There was a microcatheter returned with the device and was found to be intact.Additional information received from the customer indicated there was no damage noted to the packaging prior to preparation of the device, there were no anomalies noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu and continuous flush was maintained throughout the procedure.Also, the additional information indicated that the patient¿s anatomy was tortuous which may have contributed to the event.An assignable cause of procedural factors will be assigned to the reported 'retriever fracture/broken during use' and to the analysed 'retriever core wire broken during use', ¿retriever core wire kinked' and 'retriever coils damaged', 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 28MM - 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: 12072206
• Report Number: 3012931345-2021-00100
• Device Sequence Number: 4166083
• Product Code: POL
• UDI-Device Identifier: 07613327299939
• UDI-Public: 07613327299939
• Combination Product (Y/N): N
• 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): 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2023
• Device Model Number: 90313
• Device Catalogue Number: 90313
• Device Lot Number: 0000058516
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNCHRO 2 STANDARD (STRYKER MANUFACTURER); TRACK 21 ( STRYKER MANUFACTURER); ZOOM 71 (UNKNOWN MANUFACTURER); ZOOM 88 (UNKNOWN MANUFACTURER)