MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; ANNULOPLASTY RING

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 05/26/2018

Event Type  Injury  

Manufacturer Narrative

The causes of re-operation for a failed annuloplasty repairs are well documented in the literature.Re-operations are primarily the result of a progression of disease or technical failures and are not related to product malfunctions.Unlike prosthetic heart valves, annuloplasty rings are an adjunct to the valve repair.In this case, the patient required intervention as the size of the implanted ring was a bit too small for the long term.Based on the available information, the root cause for the event was likely due to patient related factors and procedural factors.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.[(b)(4)].

Event Description

Edwards reviewed the article, "mitral valve repair for pure mitral regurgitation followed years later by mitral valve replacement for mitral stenosis" by tiffany m.Becker et al.Abstract - we describe herein 2 patients who developed severe mitral stenosis (ms) approximately two decades after a mitral valve repair operation for pure mitral regurgitation (mr) secondary to mitral valve prolapse.This report s purpose is to point ¿ out that use of a circumferential mitral annular ring during the repair has the potential to produce a transmitral pressure gradient just like that occurring after mitral valve replacement utilizing a mechanical prosthesis or a bioprosthesis in the mitral position.Within this article, the following complaint was identified: 1 mitral ring explant after an approximate implant duration of 21 years due to severe mitral stenosis.A non-edwards mechanical valve was implanted in replacement.The author alleged the size of the implanted ring was "a bit too small for the long term"."focal fibrous thickening of the leaflets due to constant abnormal contact" was noted.

• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7616252
• MDR Text Key: 111617299
• Report Number: 2015691-2018-02349
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2018
• Initial Date FDA Received: 06/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR