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

Model Number 5200M28

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

This event is related to report number 2015691-2018-00225.The device was returned for evaluation.The clinical observation of mitral stenosis could not be confirmed through visual examination.X-ray demonstrated ring intact.Moderate to heavy host tissue was observed on the ring.The cloth was observed to be cut at few locations on the ring.Straight and even cuts across some of the cloth bundles were observed.The silicone was cut underneath one of the cloth cuts.Cor-knots remained attached around the ring.Fragments of what appeared to be subvalvular apparatus were returned with the ring.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.In addition, the event does not allege a labeling issue or device related infection; therefore, no dhr is required.A manufacturing non-conformances was not identified.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.The causes of re-operation for a failed annuloplasty repairs are well documented in the literature.Re-operations are primarily the result of a progression of disease or technical failures and are not related to product malfunctions.In this case, moderate to heavy host tissue was observed on the ring during product evaluation.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.The instructions for use (ifu) has been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaint trend was reviewed and found to be in control.Edwards will continue to review and monitor all events through the use of edwards quality systems.No further corrective or preventative actions are required at this time.

Event Description

It was reported via implant patient registry that a patient underwent redo surgery to remove his 28mm mitral annuloplasty ring due to mitral stenosis after implant duration of five months.The surgery performed included mitral valve replacement with a 31mm unknown bioprosthetic mitral valve, aortic valve replacement with a 25mm bioprosthetic aortic valve, tricuspid valve replacement with a 33mm bioprosthetic valve, coronary artery bypass x1 using svg to om, and placement of epicardial pacemaker leads.Intraoperative, after placing the patient on bypass and the aorta cross-clamp, the aortic valve was examined.A prosthetic valve was identified with severe paravalvular leak without calcification.The valve was removed and the annulus measured to a 25mm bioprosthetic valve.Then the surgical team turned their attention to the mitral valve.The mitral valve was examined.The mitral valve was found to have a small ring and sclerotic leaflets.The ring was resected and the valve partially resected.The surgical team selected a 31mm biological prosthesis and was implanted without any difficulty.Examination of the ventricular cavity showed no obstruction of the outflow tract by the valve.Then the aortic 25mm valve was implanted without any difficulty.The aortic valve was checked and ventricular cavity was copiously irrigated.The aorta was closed.Then the surgical team turned their attention to right atrium.The pacemaker lead had destroyed the previously implanted unknown prosthetic tricuspid valve.The lead was removed and a 33mm bioprosthetic vale was selected and implanted.The right atrium was closed.Then the patient was warmed and the cross-clamp removed and weaned from cardiopulmonary bypass without any difficulty.The patient was hemodynamically stable and was transferred to the intensive care unit in guarded condition.

• 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 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7357813
• MDR Text Key: 103049019
• Report Number: 2015691-2018-01008
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: 5200M28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• 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: 80 YR