MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	11400M33
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 33mm 11400m valve in the mitral position underwent a valve-in-valve procedure after an implant duration of 1 year, 4 months and 25 days due severe leaflet calcification, severe stenosis, degeneration and mild regurgitation.The patient presented with acute combined systolic and diastolic heart failure.The tmvr was performed with a 29mm 9755rsl transcatheter valve.The patient was transferred to recovery in stable condition.The patient was discharged on pod #2.Per medical records: the patient presented 1 year 4months and 5 days post redo mvr in acute respiratory failure secondary acute combined systolic and diastolic heart failure, nyha class 111-1v, and bioprosthetic av and mv stenosis.Echo showed ef 31%.Tee showed bioprosthetic valves: severe ms, mild mr due to degenerative changes of mv, the leaflets severely calcified and fixed and moderate to severe as, aortic valve with calcification, well seated tricuspid valve with mild regurgitation, mild leaflet thickening, and degenerative changes of the valve.Cath revealed severe lad stenosis.The patient underwent pci with stent placement (4/9/24), tavr (4/11/24, 2024-08959-01) twelve days prior to tmvr procedure((b)(6) 2024).
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.
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.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valves hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors, including hyperlipidemia (hld), end-stage renal disease (esrd), chronic kidney disease (ckd), chronic hepatitis b, and cirrhosis of the liver.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19347529
• Report Number: 2015691-2024-03724
• Device Sequence Number: 2582245
• Product Code: DYE
• UDI-Device Identifier: 00690103205572
• UDI-Public: (01)00690103205572(17)240907(11)220908
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 09/07/2024
• Device Model Number: 11400M33
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Male