MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90184
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the basilar artery acute thrombectomy case, resistance was felt while inserting the subject retriever into the microcatheter hub and within the microcatheter.The physician was able to move the subject retriever with resistance and completed the first thrombectomy pass.On withdrawing, resistance was felt while removing the subject retriever out of the patient vessel.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the basilar artery acute thrombectomy case, resistance was felt while inserting the subject retriever into the microcatheter hub and within the microcatheter.The physician was able to move the subject retriever with resistance and completed the first thrombectomy pass.On withdrawing, resistance was felt while removing the subject retriever out of the patient vessel.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.Visual & microscope inspection: the retriever was returned within the insertion tool.The insertion tool was intact.The retriever coils were overlapping.There was procedural fluid on the shaped section.The retriever shaped section was intact.The core wire was intact.Functional test: the insertion tool was flushed and the retriever was advanced and retracted from the insertion tool without issue.A demonstration catheter was flushed and the retriever was advanced through the catheter hub without issue.The retriever was advanced thought the catheter shaft, slight resistance was felt.There was friction felt withdrawing the retriever.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 event was confirmed during the device analysis.The device failed to meet specification when returned based on the damage noted.As per the available information, the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The device was returned and it was noted that there was damage to the retriever coils.The coils may have become damaged due to some procedural factors, the damaged coils would have caused friction advancing and withdrawing the retriever in the catheter.An assignable cause of procedural factors will be assigned to the as reported "device difficulty engaging target vessel, retriever difficult/unable to go though catheter hub and difficult/unable to withdraw retriever" and as analyzed "retriever difficult/unable to go through catheter shaft', difficult/unable to withdraw retriever' 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 PROVUE 4MM X 20MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• 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: 15156610
• Report Number: 3012931345-2022-00150
• Device Sequence Number: 14769470
• Product Code: NRY
• UDI-Device Identifier: 00815742001846
• UDI-Public: 00815742001846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120961
• 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): 10/13/2022

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: 06/27/2023
• Device Model Number: 90184
• Device Catalogue Number: 90184
• Device Lot Number: 0000066518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2021
• 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: TREVO PRO 18 (MICROCATHETER)
• Patient Sex: Unknown