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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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Reference Number:	mdprc 036 08 16 001
Date submitted:	8/31/2016

Manufacturer:	Medtronic SA
Device Type:	EnVeo R Delivery Catheter System
Description:	Aortic transcatheter heart valve bioprosthesis
Medical Device Identifier:	Model number: ENVEOR-L ……………………… TGA update code : Models: ENVEOR-L-C
Reason of Field Safety Corrective Action:	A review was completed of all Evolut R product complaints that indicated vascular trauma during use of the EnVeo R Delivery Catheter System (DCS) from the date of the first commercial Evolut R product (August 2014) through May 2016. This review identified a total of 39 events (occurrence rate of 0,136%), each of which reported insertion, advancement, or positioning difficulties associated with complicated patient anatomy (tortuosity, calcification, bicuspid valve, or existing bioprosthesis). The cause of these vascular trauma complaints has been determined to be related to the difficulties maneuvering the EnVeo DCS in tortuous or highly calcified patient anatomy, which resulted in physicians manipulating or applying extra force to the DCS, leading to vascular trauma in a small sub-set of attempted Evolut R implants. There is no indication of any non-conformance or failure of the DCS to meet requirements.
Remedy Action:	Medtronic will deliver a FSN to affected customers to provide patient anatomy considerations and recommendations regarding procedural use to reduce the rate of vascular trauma events. The Evolut R System Instructions for Use (IFU) will also be updated appropriately consistent with the information in the FSN.
Athorized Representative/Importer/Distributor:	Medtronic Saudi Arabia
Report Source:	http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01015-1
Source Ref. Number:	RC-2016-RN-01015-1
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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