MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE RETRIEVER 6X25; CATHETER, THROMBUS RETRIEVER

Catalog Number	93068
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that after the second pass with the subject device during the thrombectomy procedure, some ¿wire like¿ metallic material was noted separating from the device.Therefore, the physician elected to stop the procedure with m1 occlusion not open, as other devices were used prior to the attempts with the subject device but was unable to remove the clot.No patient harm was reported.
Additional Manufacturer Narrative
D3/h3 product available to stryker: updated.D10 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.H3 summary attached: updated.The device history record (dhr) review could not be performed as the lot number was not provided.During the analysis of the returned device, there were no visual defects found with the subject device.Therefore, the reported complaint that metallic "wire like" material was separating from the device was not confirmed.The microcatheter used in the procedure was also returned with the subject device and resistance was noted while advancing the subject device through the microcatheter due to the damage on the microcatheter.Although, no defects were noted to the struts of the retriever, it is possible that the reported clot integration issue was due to procedural factors encountered during use as it was mentioned that other devices used prior to the subject device were also unable to remove the clot.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that after the second pass with the subject device during the thrombectomy procedure, some ¿wire like¿ metallic material was noted separating from the device.Therefore, the physician elected to stop the procedure with m1 occlusion not open, as other devices were used prior to the attempts with the subject device but was unable to remove the clot.No patient harm was reported.

• Brand Name: TREVO XP PROVUE RETRIEVER 6X25
• 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: 8893999
• Report Number: 3012931345-2019-00068
• Device Sequence Number: 13525477
• Product Code: NRY
• UDI-Device Identifier: 00815742000689
• UDI-Public: 00815742000689
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 10/14/2019

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: 93068
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 10/14/2019
• 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); MICROCATHETER (UNKNOWN MANUFACTURER)