MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number 5200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ring 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 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 or from endocarditis.In this case, the surgeon implanted a larger ring at reoperation, so it is possible the ring had been mis-sized originally.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

The following article was reviewed: ¿two cases of the ring dehiscence after mitral valvuloplasty which were visualized by 3d transesophageal echocardiography.¿ - the 63th annual scientific session of the (b)(6) college of cardiology.Edwards learned that a 32mm mitral annuloplasty ring, implanted approximately three (3) years and four (4) months, was explanted due to severe mitral regurgitation secondary to ring dehiscence.This ring was originally implanted for mitral valvuloplasty to correct severe mitral regurgitation caused by mitral annulus enlargement.The postoperative course was good, however severe mitral regurgitation was detected by transthoracic echocardiography, which was performed for follow-ups after a year and a half.After that, hemolytic anemia and heart failure were progressed, so a 3d transesophageal echocardiography was performed for detailed examination.3d tee showed that the ring at the patient¿s native posterior cusp at p2 was prolapsed, and severe mitral regurgitation from a gap, which was made between the ring and patient¿s native annulus.The ring was explanted and replaced with a 34mm medtronic cg future ring.At explant, the ring dehiscence at the patient¿s native posterior cusp at p2 was confirmed, so the findings were consistent with the 3d tee before the operation.Three sutures were added to the area where the ring dehiscence occurred previous time.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 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: 6888694
• MDR Text Key: 87195053
• Report Number: 2015691-2017-03051
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2017

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 Model Number: 5200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/22/2017
• 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