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

Model Number	4450M
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the dhr review was started and finished in irvine.There are no related ncrs.The dhr review is complete.Draper wo (b)(4).Per (b)(4), "the causes of reoperation following a failed annuloplasty repair is well-documented in medical literature.Typically, reintervention on the annuloplasty ring occurs due to factors such as progression of valvular heart disease, rather than inherent structural deficiency in the annuloplasty ring itself.Over time, the underlying heart condition that initially required repair may worsen, leading to further valve deterioration.This ultimately affects the durability of the initial repair, necessitating re-intervention.Other contributing factors include the emergence of new pathologies (such as infective endocarditis or degenerative changes), the patient's baseline hemodynamics, anatomical alterations, and procedural considerations." there is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely root cause is patient and/or procedural factors.
Event or Problem Description
It was reported and learned through investigation that a patient with a 36mm 4450 mitral ring was explanted after an implant duration of 8 years and two months due to regurgitation and dehiscence.The explanted ring was replaced with 31mm 11400m mitris resilia mitral valve.The patient was transferred to the icu before being discharged in stable condition.Per pa, the perceived root cause of the event was due to structural deficiency of the annuloplasty ring.

• Brand Name: CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• 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: 21649855
• Report Number: 2015691-2025-02080
• Device Sequence Number: 15325876
• Product Code: KRH
• UDI-Device Identifier: 00690103020274
• UDI-Public: (01)00690103020274(17)190527(11)140528
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K926138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2019
• Device Model Number: 4450M
• 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: 02/27/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2014
• 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; Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male