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

Model Number	5300M30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards learned that this 30mm 5300m ring was explanted at implant due to mitral regurgitation.After decannulation before closing the patient's chest, regurgitation was still detected.The device was explanted and replaced with a 27mm 11400m valve with no adverse patient events reported.The patient status was reported as "under treatment".The device was not returned for evaluation as it was discarded at the hospital.There was no allegation of device malfunction.This device was originally implanted for mitral valvuloplasty to correct mitral regurgitation with a concomitant aortic valve replacement with a 21 mm 11500aj valve.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Surgeons often attempt to repair valves in lieu of replacing them due to improved long-term clinical outcomes.There are times when a valve repair is attempted using an annuloplasty ring and subsequent post-repair evaluation demonstrates an inadequate result.This is almost universally due to suboptimal anatomy, surgical technique or inappropriate sizing, and not a malfunction of the annuloplasty ring.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• Brand Name: PHYSIO FLEX ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14659270
• Report Number: 2015691-2022-06156
• Device Sequence Number: 20312823
• Product Code: KRH
• UDI-Device Identifier: 00690103206197
• UDI-Public: (01)00690103206197(17)261213(11)211214219402369
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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 Model Number: 5300M30
• Device Catalogue Number: 5300M30
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/19/2022
• Date Device Manufactured: 12/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 61 KG