• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ANNULOPLASTY RING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EDWARDS LIFESCIENCES ANNULOPLASTY RING Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceANNULOPLASTY 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 Key7616252
MDR Text Key111617299
Report Number2015691-2018-02349
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 05/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/19/2018 Patient Sequence Number: 1
-
-