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

Model Number 5200M40

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded by the hospital staff.The clinical observation was unable to 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.A definitive root cause cannot be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.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 a mitral annuloplasty ring, implanted approximately four (4) years and three (3) months, was explanted due to severe mitral stenosis and regurgitation secondary to pannus growth.This device was originally implanted at different facility due to mitral stenosis and regurgitation.At explant, the leaflet mobility was restricted by pannus which was grown over the entire patient¿s anterior cusp.The device was explanted and replaced with a smaller size same model while the patient was on bypass with no adverse patient effects reported as a result of the ring replacement.The patient status was reported as ¿under treatment¿ at icu.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA
• Manufacturer Contact: neil landry ; 1 edwards way; ms mle2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6619827
• MDR Text Key: 76913597
• Report Number: 2015691-2017-01630
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/16/2017

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: 5200M40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/07/2017
• 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: 54 YR