MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER

Model Number	90186
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the stent (subject device) got detached from the delivery wire and remained inside the support catheter used during the procedure.The core wire of the subject device was damaged.Both the detached subject stent and the catheter were successfully removed 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 procedure, the stent (subject device) got detached from the delivery wire and remained inside the support catheter used during the procedure.The core wire of the subject device was damaged.Both the detached subject stent and the catheter were successfully removed 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
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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 with a non-stryker guide catheter (sofia) and the guide catheter was noted to be kinked in a number of locations.The retriever coil was kinked/damaged and the retriever core wire was broken/fractured.The retriever shaped section with intact distal fracture region was returned.Sem imaging of the fractured core wire (both distal and proximal fragment) were performed and the fracture location was confirmed at the round-to-flat transition area on core wire.The fracture surface was observed to have a "two-zone" fracture; where both brittle fracture and ductile fracture regions are present.There was noticeable crack on the side of the core wire surface.A functional test was unable to be performed due to the damage noted to the device.Additional information was received indicating that the device was prepared as per the dfu, no anomalies noted to the device after removal from the packaging or prior to preparation, and continuous flush was maintained throughout the procedure.Based on the information provided, it is most likely that the trevo retriever stent became dislodged from the device itself due to anatomical or procedural factors encountered during the procedure.An assignable cause of 'procedural factors' will be assigned to the as reported and as analyzed events, as this issue appears to be 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.This complaint has been identified to be within the scope of nc# 2425934, which was raised for core wire fractures.The subsequent investigation of this nc led to containment and recall per hhe# 2430533.

• Brand Name: TREVO XP PROVUE 6MM X 25MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10437586
• Report Number: 3012931345-2020-00118
• Device Sequence Number: 2676616
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K143077
• 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): 10/18/2020

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: 08/18/2021
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000031587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 10/18/2020
• 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: SOFIA 6F CATHETER (MICROVENTION); SOFIA 6F CATHETER (MICROVENTION)
• Patient Age: 60 YR