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

Model Number 4450M28

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 04/04/2014

Event Type  Injury  

Event Description

An annuloplasty ring, implanted in the mitral position four years and six months, was explanted due to severe pannus ingrowth and stenosis.The explanted device was replaced with a pericardial valve.It was further reported that tests confirmed annular pannus with fibrosis and patchy chronic inflammation.

Manufacturer Narrative

(b)(4).The device was not returned to edwards for analysis.Device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.Without the return of the device, edwards is unable to confirm the clinical observation.Edwards will continue to review and monitor all events.Trends are monitored on a (b)(4) basis and if action is required, appropriate investigation will be performed.

• Brand Name: CARPENTIER-EDWARDS® PHYSIO 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 ; lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 3914504
• MDR Text Key: 4514972
• Report Number: 2015691-2014-01536
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K926138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2014

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 Model Number: 4450M28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 07/03/2014
• 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): Required Intervention
• Patient Age: 30