MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM; ANNULOPLASTY RING

Model Number 4900

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Tricuspid Regurgitation (2112); Tricuspid Valve Stenosis (2113)

Event Date 12/06/2013

Event Type  Injury  

Event Description

In this case, edwards received information that this patient had explant of a tricuspid annuloplasty ring, implanted approximately 17 months, due to tricuspid stenosis and regurgitation.It was identified, through review of source documentation provided, that the tricuspid ring had a single suture dehiscence along the septal leaflet.There was also pannus involving the tricuspid leaflets themselves which also were scarred and restricted.The ring was explanted and the patient's tricuspid valve was replaced with an edwards bioprosthetic valve.There were no adverse patient effects as a result of the replacement reported.

Manufacturer Narrative

(b)(4).It was reported that the annuloplasty ring was explanted due to tricuspid stenosis and regurgitation with pannus growth and dehiscence.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.Ring or valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair or prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.There have not been any allegations of a malfunction or deficiency related to the explanted ring.It appears that technique and patient related factors likely caused or contributed to this event.Unfortunately, there is insufficient information to conclusively determine the root cause of this event.No further actions are possible with the available information.

• Brand Name: EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 3625497
• MDR Text Key: 4207857
• Report Number: 2015691-2014-00332
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2014

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
• Device Expiration Date: 11/02/2016
• Device Model Number: 4900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2014
• Initial Date FDA Received: 02/12/2014
• Date Device Manufactured: 11/09/2011
• 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; Life Threatening; Required Intervention
• Patient Age: 64 YR