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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the subject retriever fell apart from attachment point to the wire when pulled back into catheter along with the microcatheter.The subject retriever left in the artery, and partially in the catheter then it was pulled back slowly.The subject retriever was successfully removed from the patient's body in the end.The procedure was not completed due to another reason.No other information was provided.
Event or Problem Description
It was reported that the subject retriever fell apart from attachment point to the wire when pulled back into catheter along with the microcatheter.The subject retriever left in the artery and partially in the catheter then it was pulled back slowly.The subject retriever was successfully removed from the patient's body in the end.The procedure was not completed due to another reason.No other information was provided.
Additional Manufacturer Narrative
Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Analysis of the returned device found that the subject retriever shaped section was detached from the core wire.The core wire was fractured at 4.7mm from the mid solder junction.The core wire coil was removed in order to inspect the proximal end of the core wire break.The microscope confirmed fracture was at transition region from round-to-flat corewire and shows a moderate degree of contamination as shown by darker "flakes" in the images (likely dried procedural fluids/matter).In addition, the images indicate that the fracture site experienced both ductile and brittle fracture.Based on the device analysis the reported event was confirmed.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 was received indicating that the device was prepared as per the dfu, no anomalies were noted to the device after removal from the packaging or prior to preparation, and continuous flush was maintained throughout the procedure.The device was returned and it was confirmed that the retriever had become detached from the core wire due to a fracture to the core wire.It is probable that the core wire fractured during difficulties encountered during manipulation of the device.An assignable cause of procedural factor will be assigned to the reported nv - retriever fractured/broken during use and analysed ' retriever core wire broken during use, 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.

• 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: 10870269
• Report Number: 3012931345-2020-00201
• Device Sequence Number: 3006050
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 03/02/2021

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: 07/08/2021
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000029499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/14/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 03/02/2021
• 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: MICROCATHETER (UNKNOWN MANUFACTURER); SOPHIA CATHETER