MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO PROVUE; CATHETER, THROMBUS RETRIEVER

Catalog Number	90184
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/30/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Based on the information currently available the reported patient death is a known and anticipated complication to these types of procedures and patient condition, and is listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complications has been assigned to the reported patient death.The subject device is not available.
Event or Problem Description
It was reported that the patient died for unknown reason after thrombectomy procedure at the right mca (middle carotid artery) m1.The death occurred between 34 to 102 days post procedure.7 days post-procedure, the patient¿s mrs (modified rankin scale) was 4 and the nihss (national institutes of health stroke scale) was 10.In addition, 34 days post-procedure, the patient¿s mrs was 4 as well.No further information is provided for now.

• Brand Name: TREVO PROVUE
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 9099828
• Report Number: 0002954917-2019-00007
• Device Sequence Number: 2831316
• Product Code: NRY
• UDI-Device Identifier: 00815742001846
• UDI-Public: 00815742001846
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K133464
• 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
• Report Date (Section B): 09/20/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2019
• Device Catalogue Number: 90184
• Device Lot Number: 63119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR