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

Model Number	4450
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gradient Increase (1270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: additional 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.
Event or Problem Description
It was reported that an unknown model valve in the mitral position was disabled via a valve-in-valve procedure after an unknown implant duration due to mitral stenosis and regurgitation.A 9755rsl 29mm transcatheter valve was successfully implanted.
Event or Problem Description
It was reported that a 36mm 4450 mitral ring was disabled via a valve-in-ring procedure after an implant duration of one year and eight months due to mitral stenosis and regurgitation.A 9755rsl 29mm transcatheter valve was successfully implanted.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: b4, b5, d1, d2, d4, d6, g3, g4, g6, h2, h4, 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.The causes of surgical or percutaneous intervention for failed annuloplasty repairs are well documented in the literature.This is primarily due to progression of native valvular disease or technical failures and is not related to device malfunction.This may present as recurrent regurgitation and/or stenosis.Unlike prosthetic heart valves, annuloplasty rings are an adjunct to the valve repair.Per technical summary 26579, rev a, [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.The most likely cause is patient factors, including progression of the patient's disease.H11: corrective data: based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16853251
• Report Number: 2015691-2023-12704
• Device Sequence Number: 6248814
• Product Code: KRH
• UDI-Device Identifier: 00690103020274
• UDI-Public: (01)00690103020274(17)260223
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K926138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2026
• Device Model Number: 4450
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female