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	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the physician was trying to remove the subject stent retriever but the junction between the stent and the wire broke as soon as it was pulled.Another retriever was used to retrieve the broken part, but it was unable to be removed and left inside the patient¿s anatomy.The procedure was completed, and patient had no other abnormal symptoms reported.No further information is available.
Event or Problem Description
It was reported that during the procedure, the physician was trying to remove the subject stent retriever but the junction between the stent and the wire broke as soon as it was pulled.Another retriever was used to retrieve the broken part, but it was unable to be removed and left inside the patient¿s anatomy.The procedure was completed, and patient had no other abnormal symptoms reported.No further information is available.
Additional Manufacturer Narrative
A review of the device history record (dhr) for non-conforming issues and/or events was conducted for this batch.No non-conformances were raised.Although the scrapped devices could potentially relate to the reported event, the devices are inspected for damages/defects as per work instructions prior to release and all rejected devices are segregated and scrapped.Therefore, it does not appear that the lot manufacture had caused or contributed to the reported event.The dhr review indicated that all released products met specifications.Additional information provided by the customer indicated preparation/set-up was performed as per the directions for use, continuous flush maintained for the duration of the procedure, the patient anatomy was very tortuous, and no resistance encountered during the procedure.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned, a cause of 'undeterminable' shall be assigned to the as reported events.

• 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: 10483481
• Report Number: 3012931345-2020-00126
• Device Sequence Number: 2815971
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 11/03/2020

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: 07/28/2021
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000030419
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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: XT-27 MICRO CATHETER (STRYKER); XT-27 MICRO CATHETER (STRYKER)