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	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the middle cerebral artery clot retrieval procedure, the distal access catheter and microcatheter coaxially advanced distal to the lesion navigated by the guidewire.The subject device was passed through the stented artery and deployed inside the patient's anatomy.During the first pass, recanalization was not achieved.Therefore, a second pass was performed as same as the first pass.While retrieving the subject retriever, it's got stuck in the patient's anatomy and not able to be removed.The physician advanced the distal access catheter to cover the subject retriever and removed together from the patient's anatomy.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 the middle cerebral artery clot retrieval procedure, the distal access catheter and microcatheter coaxially advanced distal to the lesion navigated by the guidewire.The subject device was passed through the stented artery and deployed inside the patient's anatomy.During the first pass, recanalization was not achieved.Therefore, a second pass was performed as same as the first pass.While retrieving the subject retriever, it's got stuck in the patient's anatomy and not able to be removed.The physician advanced the distal access catheter to cover the subject retriever and removed together from the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Device evaluated by mfg ¿updated.Summary attached - updated.Manufacturing date ¿ added.Expiration date - added.The device history record (dhr) confirms that the device met all material, assembly and performance specifications.During visual inspection, the retriever shaped section was damaged and there was procedural fluid on the shaped section.The retriever shaped section strut was found broken and the core wire was found kinked.The pebax was damaged at the mid solder.Functional testing could not be confirmed as the subject device was damaged.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepare as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the tortuosity of the patient's anatomy was normal, resistance was encountered in the vessel during the procedure, the retriever passed through a stented artery (middle cerebral artery), and the procedure was completed by covering the device with a distal access catheter to retrieve the clot.During analysis, the retriever shaped section was found to be damaged with one of the stent struts observed to be broken.Additionally, the core wire was found to be kinked and the pebax was damaged at the mid solder joint.Given that there was resistance noted in the vessel likely due to the retriever passing through a stented artery (middle cerebral artery), it appears that the device was subject to forces during the procedure that led to the observed defects and reported event.An assignable cause of procedural factors will be assigned to the as reported 'difficult/unable to withdraw retriever' and 'retriever clot integration issue' as well as the as analyzed 'retriever platinum wire damage/break', 'retriever shaped section damage' and 'retriever core wire kinked' since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.

• 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: 13803586
• Report Number: 3012931345-2022-00049
• Device Sequence Number: 4994321
• 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): 07/22/2022

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: 04/26/2023
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 62935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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 DISTAL ACCESS CATHETER (STRYKER); CHIKAI 14 GUIDEWIRE (ASAHI INTECC); TREVO TRAK 21 MICROCATHETER (STRYKER)
• Patient Sex: Unknown