Edwards PASCAL Transcatheter Valve Repair System (2019-04-28)

Starting date:

April 28, 2019

Posting date:

May 24, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70013

Last updated: 2019-05-24

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  Reason
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  Affected products

Affected Products

Edwards PASCAL Transcatheter Valve Repair System

Reason

A potential procedural factor has been identified by Edwards, which may occur during the use of the pascal transcatheter valve repair system.  In a limited number of cases, observations of air bubbles have been made following insertion of the Implant System into the Guide Sheath.  Although air bubbles are commonly observed during use of transcatheter devices, in at least one case it is believed that the introduction of air resulted in a coronary air embolism, which required medical intervention to stabilize the patient before successfully completing the PASCAL procedure.  Edwards is taking this opportunity to update the physician training materials to add clarity around the minimum volume of aspiration required and specifics for de-airing tools and techniques.

Affected products