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

Model Number	5200M
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: attempts have been made to obtain product for evaluation.No device was returned.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 learned from the medical record of (b)(6) that the 5200 carpentier-edwards physio ii annuloplasty ring was explanted after an implant duration of two (2) years and five (5) months due to ring dehiscence with large pseudoaneurysm and severe mitral stenosis.The explant ring was replaced with a 29mm non-edwards valve.Per medical records, the patient was asymptomatic.Intraoperatively, there was giant aneurysm in aortic root with fistula formation to la over mitral annuloplasty ring.The old prosthetic 23mm inspiris valve was explanted (b)(6).The 32mm 5200 annuloplasty ring was also loosely connected to annulus and was explanted.The giant pseudoaneurysm destroyed anterior mitral leaflet, aortornitral curtain, and perinuclear tissue.The mitral valve was replaced with a 29mm non-edwards valve with reconstruction of aortomitral curtain with bovine pericardial patch (commando procedure), aortic root replacement with 23mm konnect avc and rvot repair another bovine pericardial patch.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.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions).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.Per the instructions for use (ifu), structural valve deterioration (svd) is a known potential risk associated with bioprosthetic heart valves.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.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.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Common Device Name: 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: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 22311857
• Report Number: 2015691-2025-05107
• Device Sequence Number: 13008975
• Product Code: KRH
• UDI-Device Identifier: 00690103180213
• UDI-Public: (01)00690103180213(17)270629
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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 Model Number: 5200M
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2022
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female