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

Model Number 445034MM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The explanted ring has been returned for evaluation; however, the analysis is still in progress.A supplemental report will be submitted according once the product evaluation has been completed.

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.In this case, it was reported that a 34mm annuloplasty ring, implanted in the mitral position for approximately four (4) years and five (5) months, was explanted due to dehiscence and regurgitation.Echocardiogram of the native valve revealed an ef 45%, mr with posterior prolapse and non coaptation, dehiscence of mitral ring off of a2 to p2 laterally and was significantly oversized and trace tr.The leaflets were thickened and immobile and re-repair was not a option.The annulus was intact and the chordae were preserved.After inspection of the mitral valve and removal of the ring, the decision was made to replace the valve based on poor leaflet tissue quality.The explanted device was replaced with a 29mm edwards bioprosthetic mitral valve.The valve was seated and secured into place.The patient was weaned from cpb and transferred to cticu intubated and in stable condition.Post operative tee showed no paravalvular leaks and no mr.

Manufacturer Narrative

Customer report of dehiscence and regurgitation could not be confirmed through visual observations.X-ray demonstrated ring intact.The cloth and silicone was cut at multiple locations around the ring.Straight and even cuts across the cloth bundles were observed on the cuts.Sutures were observed on the ring.Minimal host tissue growth was observed on ring.Ring dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.The body undergoes various phases of the tissue response continuum post-operatively 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, a definitive root cause for the regurgitation, dehiscence and pannus could not be conclusively determined, but the progression of the patient¿s disease is the probable root cause.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards will continue to review of all reported events and perform trend analysis on a monthly basis.If action is required, appropriate investigation will be performed.

• Brand Name: CARPENTIER-EDWARDS PHYSIO 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; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7000420
• MDR Text Key: 91004685
• Report Number: 2015691-2017-03693
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

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 Expiration Date: 11/30/2014
• Device Model Number: 445034MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2010
• 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: 52 YR