MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE RETRIEVER 4X30; CATHETER, THROMBUS RETRIEVER

Catalog Number	90185
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that the subject stent retriever was broken while trying to remove thrombus from the patient's anatomy during the procedure.No further information is available.
Event or Problem Description
It was reported that the subject stent retriever was broken while trying to remove thrombus from the patient's anatomy during the procedure.No further information is available.
Additional Manufacturer Narrative
Although the dhr could not be reviewed because the lot number/serial number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned.Therefore, visual analysis and functional analysis were not performed.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.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 for analysis, a cause of undeterminable was assigned to the reported event.H3 other text : the subject device is not available to the manufacturer.

• Brand Name: TREVO XP PROVUE RETRIEVER 4X30
• 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: 9441189
• Report Number: 3012931345-2019-00100
• Device Sequence Number: 2335650
• Product Code: NRY
• UDI-Device Identifier: 00815742000672
• UDI-Public: 00815742000672
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K150616
• 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): 01/09/2020

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 Catalogue Number: 90185
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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: SYNCHRO GUIDEWIRE(STRYKER); TREVO PRO 18 MICROCATHETER(STRYKER)