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 Valve Stenosis (1965)

Event Date 09/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: the product was returned for evaluation.Customer report of mitral stenosis could not be confirmed through visual observations.Report of pannus growth was not confirmed.X-ray demonstrated ring intact.Cuts were observed on the cloth and silicone around the ring.Sutures remained attached.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.Based on the information received, a definitive root cause cannot be determined.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that this 28 mm mitral annuloplasty ring, implanted approximately three (3) years and two (2) months, was explanted due to mitral stenosis secondary to pannus growth.This device was originally implanted for mitral valvuloplasty to correct mitral regurgitation.This device was explanted and replaced with a 27 mm valve with no adverse patient effects reported as a result of the valve replacement.The condition of the valve at explant was reported as ¿pannus growth on this ring was observed and it led to mitral stenosis¿.The patient status was reported as ¿recovered¿ at icu.The device was returned for evaluation.There was no allegation of device malfunction.Multiple cardiac surgical procedure: aortic valve replacement with a 25 mm valve.

Manufacturer Narrative

The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.

• 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; lfs-33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6922956
• MDR Text Key: 88934078
• Report Number: 2015691-2017-03263
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2014
• 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): Required Intervention
• Patient Age: 64 YR