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 Regurgitation (1964)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: the clinical observation of regurgitation could not be confirmed through visual observations.X-ray demonstrated ring intact.Heavy host tissue was observed on the ring.The cloth and silicone was observed to be cut at few locations around the ring.Straight and even cuts across some of the cloth bundles were observed.Additional manufacturer narrative: based on the product evaluation findings, the most likely root cause is patient's clinical condition.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.Host fibrotic tissue (pannus) growth is considered a part of the local host response to the initial tissue injury during surgery and as well as an ongoing response to the implanted device.The process usually results from acute and chronic inflammation, which can be triggered by trauma, a foreign body reaction, infection, or other immune responses to the implant.As such, it is extremely difficult to predict the occurrence and severity of pannus overgrowth, and the resultant pannus deposition is highly variable among patients.A manufacturing non-conformance was not identified.There was no indication or allegation of a device malfunction contributing to the event.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.Edwards will continue to review and monitor all events through the use of edwards quality systems.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No further corrective or preventative actions are required at this time.

Event Description

Edwards received information that this 28mm mitral annuloplasty ring, implanted approximately one (1) year and one (1) month, was explanted due to severe mitral regurgitation.This device was originally implanted for mics mitral valvuloplasty to correct mitral regurgitation (ejection fraction: 49%).After an implant duration of approximately one (1) year and one (1) month, ejection fraction was decreased to 36%.This device was explanted and replaced with a 25mm edwards magna mitral ease valve with no adverse patient effects reported as a result of the valve replacement.The patient status was reported as ¿under treatment¿ at in a general ward at the hospital.

• 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: 7440067
• MDR Text Key: 105801415
• Report Number: 2015691-2018-01424
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/26/2018

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: 08/01/2021
• Device Model Number: 5200M28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• 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: 73 YR
• Patient Weight: 50