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

Model Number	5200M30
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 30mm 5200m annuloplasty ring in the mitral position underwent a valve-in-ring procedure after an implant duration of seven (7) months due to mitral regurgitation.The mvir procedure was performed with a 29mm 9600tfx transcatheter valve.The patient tolerated the procedure without difficulties and was sent to recovery with stable vitals.The physician felt the annuloplasty ring did fail because it was implanted for less than one year.
Additional Manufacturer Narrative
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
Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
It was reported that a patient with a 30mm 5200m annuloplasty ring in the mitral position underwent a valve-in-ring procedure after an implant duration of seven (7) months due to mitral regurgitation.The mvir procedure was performed with a 29mm 9600tfx transcatheter valve.The patient tolerated the procedure without difficulties and was sent to recovery with stable vitals.The physician felt the annuloplasty ring did fail because it was implanted for less than one year.There were no structural deficiencies or malfunctions of the subject device.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 91761
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15316464
• Report Number: 2015691-2022-07592
• Device Sequence Number: 5230203
• Product Code: KRH
• UDI-Device Identifier: 00690103180206
• UDI-Public: (01)00690103180206(17)261005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K083470
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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?: Yes
• Device Model Number: 5200M30
• Device Catalogue Number: 5200M30
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/02/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Female