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

Model Number 4450

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2022

Event Type  Injury  

Event Description

Through implant patient registry, it was reported that a patient with a 26mm 4450 mitral ring, underwent a valve-in-ring procedure after an implant duration of 6 years, 5 months due to a degenerated mitral ring, moderate mr and severe mitral stenosis.The tmvr was performed with a 23mm 9750tfx transcatheter valve.

Manufacturer Narrative

The subject device is not available for evaluation, as it remains implanted in the patient.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: d4 (expiration date), h4, h2, and h6 (type of investigation, investigation findings, and investigation conclusions).The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.There may be cases where a transcatheter intervention is indicated or performed to treat recurrent regurgitation and/or stenosis after failed annuloplasty ring repair.Annuloplasty rings are an adjunct to the valve repair and recurrent regurgitation and/or stenosis occurs as a result of progression of disease and is not related to a device malfunction.Failed annuloplasty repair re-operations are primarily the result of a progression of disease, the patient's baseline hemodynamics, or technical failures and are not evidence of product malfunctions.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.H11: corrective data: corrected section: h6 (component code).

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15303217
• MDR Text Key: 298707265
• Report Number: 2015691-2022-07535
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2020
• Device Model Number: 4450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2015
• 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; Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female