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

Model Number	90182
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure in the m1 segment of left middle cerebral artery, the subject stent was used to retrieve the clot.The physician pulled the subject stent retriever, but it broke off from the delivery wire during retraction.Subject stent retriever was stuck inside patient and no attempts were made to remove it.The procedure was not completed successfully.Patient is currently on blood thinner medication and aspirin.Patient is currently recovering from procedure in the intensive care unit.
Event or Problem Description
It was reported that during a procedure in the m1 segment of left middle cerebral artery, the subject stent was used to retrieve the clot.The physician pulled the subject stent retriever, but it broke off from the delivery wire during retraction.Subject stent retriever was stuck inside patient and no attempts were made to remove it.The procedure was not completed successfully.Patient is currently on blood thinner medication and aspirin.Patient is currently recovering from procedure in the intensive care unit.
Additional Manufacturer Narrative
The device history record review confirms that there is no indication that the device, labeling or packaging failed to meet its specifications when released.The returned device was confirmed to be subject retriever listed from the returned packaging.After decontamination subject retriever was examined and it was observed that the subject stent retriever was not attached to the returned unit.The subject device core wire and shaft coil were examined.The shaft coil was damaged (kinked & stretched) and the core wire was broken/fractured.Sem imaging of the fractured core wire was performed with r&d sustaining 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.Performance testing was not performed due to the condition the device was received.From the condition of the product it appears that the product had been under excessive manipulation.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 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 subject 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 analyzed defects of 'retriever core wire broken during use', 'retriever coils damaged', and as reported defects of 'retriever fractured/broken during use' and 'un-retrieved device fragments', 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 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
• MDR Report Key: 10367623
• Report Number: 3012931345-2020-00116
• Device Sequence Number: 3044089
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132641
• 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): 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2021
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: 0000032043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/25/2020
• 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: PHENOM 027 MICROCATHETER (UNKNOWN); PHENOM 027 MICROCATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other; Required Intervention