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 04/04/2014

Event Type  Injury  

Event Description

Edwards received information that a 32mm bioprosthetic mitral ring, implanted approximately three (3) months and twenty-four (24) days, was explanted due to regurgitation secondary to ring dehiscence.The explanted device was replaced with a bioprosthetic valve.Patient tolerated the procedure well.

Manufacturer Narrative

(b)(4).Additional manufacturer narrative - the reported device was not returned to manufacturer.Without receipt of the explanted device the reported clinical observation cannot be confirmed and a root cause cannot be determined or investigated.The device history record review was completed and confirms that this device passed all manufacturing and sterilization inspections.Edwards will continue to monitor all events.Additional information will be reported if received.

• 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 ; one edwards way; ms: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 3869936
• MDR Text Key: 21803495
• Report Number: 2015691-2014-01370
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083470
• 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: 05/13/2014

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: 03/09/2018
• Device Model Number: 5200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 06/12/2014
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR