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

Model Number 5200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: ring dehiscence which occurs in the late post-operative period is typically a result of successive dilatation of cardiac structures, which can result from progression of disease or from patient conditions/factors.In this case, the explanted annuloplasty ring was not returned to edwards for analysis because it was discarded at the hospital.At this time, edwards lifesciences is unable to conclusively determine the root cause for this event.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that this 34mm annuloplasty ring was explanted after five (5) or six (6) years due to mitral regurgitation.As reported, the ring was detached at the posterior cusp area and it could have been causing regurgitation.The annuloplasty ring was replaced with a 33mm mechanical valve.The patient status was reported as ¿recovering¿ at a general ward of the hospital and the patient will be discharged soon.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• 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: t&d 2nd floor, office t223; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5922431
• MDR Text Key: 53743020
• Report Number: 2015691-2016-02644
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/10/2016

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: 08/10/2016
• Initial Date FDA Received: 09/01/2016
• 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: 62 YR