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	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during procedure when the surgeon tried to insert the retriever (subject device) into the microcatheter, a strong resistance was felt at the catheter shaft and in the middle of the microcatheter, it was difficult to advance.When the surgeon removed the retriever (subject device) and the microcatheter from body there was resistance as well.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during procedure when the surgeon tried to insert the retriever (subject device) into the microcatheter, a strong resistance was felt at the catheter shaft and in the middle of the microcatheter, it was difficult to advance.When the surgeon removed the retriever (subject device) and the microcatheter from body there was resistance as well.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the core wire was bent, the insertion tool was damaged, and the handle had moved, the retriever was intact.The returned microcatheter was intact.A functional test, the returned microcatheter was flushed and blood exited.The system was flushed, as the insertion tool was badly damaged a demo insertion tool was used.The retriever was inserted and advanced in the returned microcatheter, friction was felt advancing and retracting the retriever.The reported defect was not confirmed based on analysis of the device.The catheter device met specifications when received for complaint investigation.The reported event is covered in the device direction 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.As per the additional information, the device was prepared as per the dfu, 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 and patient¿s anatomy was averagely tortuous.The device was returned, and the retriever core wire was noted to be kinked and the insertion tool was damaged.There was blood noted within the returned microcatheter which may be an indication of insufficient flush.Resistance was experienced during advancement of the retriever during analysis, confirming the event.It is probable that the device was damaged during the clinical procedure, possibly due to the presence of blood within the microcatheter, causing the reported resistance.An assignable cause of procedural factors will be assigned to the reported ¿retriever difficult/unable to go through catheter shaft¿ and ¿difficult/unable to withdraw retriever¿ and to the analysed ¿retriever core wire kinked¿ , ¿retriever insertion tool kinked/bent (damaged)¿, ¿retriever difficult/unable to go through catheter shaft¿ and ¿difficult/unable to withdraw retriever¿, 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
• MDR Report Key: 12230161
• Report Number: 3012931345-2021-00123
• Device Sequence Number: 19955905
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 01/13/2023
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 57135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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: TRACK 21 (STRYKER MANUFACTURER).; TRACK 21 (STRYKER MANUFACTURER)
• Patient Age: 81 YR