MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM; RING, ANNULOPLASTY

Model Number	4900T32
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	06/11/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a 32mm 4900t annuloplasty ring was explanted after an implant duration of four (4) days due to conduction abnormalities post tricuspid valve repair.After initial ring implant, the patient showed signs of progressive deterioration of his conduction.Sinus rhythm was observed when first coming out of the or, and then 24 hours later, type a 2nd-degree heart block was observed with intermittent complete heart block.There were some concerns that the inferomedial aspect of the mc3 ring might be mechanically troubling the av node.Therefore, the patient was taken to the or to replace the ring.Intraoperatively, the mc3 ring was visualized and found to be creating a small indentation in the endocardium and muscle at the crux of the heart inferior to the coronary sinus ostium.It was unable to distort the ring in any meaningful way to relieve the compression.The ring was explanted and replaced with a non-edwards ring which was tailored to the patient's dysplastic annulus.The procedure was uncomplicated, and the patient rhythm improved after the removal of the cross-clamp.The patient tolerated the procedure well and returned to the icu in stable condition.This device was originally implanted to repair a tricuspid valve with ebstien i anomaly in a 15-year-old male patient.
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.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

• Brand Name: EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
• 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 CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15261298
• Report Number: 2015691-2022-07424
• Device Sequence Number: 6635905
• Product Code: KRH
• UDI-Device Identifier: 00690103182293
• UDI-Public: (01)00690103182293(17)231014
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K020864
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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 Expiration Date: 10/14/2023
• Device Model Number: 4900T32
• Device Catalogue Number: 4900T32
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 10/12/2022
• Date Device Manufactured: 10/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male