ENGAGER TRANSCATHETER AORTIC BIOPROSTHESIS (2015-07-03)

Starting date:

July 3, 2015

Posting date:

July 21, 2015

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-54322

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  Reason
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  Affected products

Affected Products

A. ENGAGER TRANSCATHETER AORTIC BIOPROSTHESIS

Reason

A review of the 2-year follow-up data of engager European pivotal trial has shown that 16 of 32 subjects implanted with a 23mm device have a mean gradient of = 20 MMHG at some point after the implant (average mean gradient at 2-year follow up: 22.0 ? 7.5 MMHG). Gradient is a measure of the resistance to flow through the valve. A mean gradient of 20-40 MMHG is associated with mild stenosis (narrowing of the valve) per the valve academic research consortium (VARC) -2 guideline.  No interventions, balloon valvuloplasty, or surgical replacement were performed related to the elevated gradient on the 16 study patients. As a result of these data, Medtronic has made the decision to voluntarily discontinue sales and distribution of the 23mm Bioprosthesis permanently. This recall affects only the 23mm Engager Bioprosthesis.

Affected products