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

Model Number 5200M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Mitral Valve Stenosis (1965)

Event Date 10/27/2014

Event Type  Injury  

Event Description

Edwards received information that a 28mm bioprosthetic mitral ring, implanted approximately three (3) years and nine (9) months, was explanted due to mitral stenosis and severe pannus overgrowth on the ring.The explanted device was replaced with a 27mm mitral valve.The operative note indicated that the patient had severe coagulopathy following the procedure; however, it was determined to be likely due to the patient's severe right sided congestive heart failure and cardiac cirrhosis.Operative observation revealed host tissue overgrowth on the ring.The patient tolerated the procedure well.

Manufacturer Narrative

(b)(4).The device was not returned to edwards for analysis.The reported clinical observation could not be confirmed.Post-operatively, the body undergoes various phases of the tissue response continuum resulting in the fibrous encapsulation of the ring.Local and systemic factors of the patient may play a role in the wound healing and inflammatory responses to biomaterials and implants.In this case, the patient's response to the ring was noted to be vigorous and excessive, contributing to the need for explanation.The device history record was reviewed and showed that this device met all manufacturing specifications prior to product being released for distribution.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 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; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4334895
• MDR Text Key: 5138029
• Report Number: 2015691-2014-03007
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2014

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: 09/30/2015
• Device Model Number: 5200M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/16/2014
• Date Device Manufactured: 11/11/2010
• 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: 69 YR
• Patient Weight: 66