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

Model Number 300021MM

Device Problems Perivalvular Leak (1457); Device Stenosis (4066)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported that an 21mm unknown model edwards valve, in the aortic position is under evaluation for a valve-in-valve procedure after implant duration of approximately 7 years due to severe insufficiency and stenosis with mild perivalvular leak.The patient presented with acute on chronic heart nyha class iii.

Manufacturer Narrative

H10: 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.

Manufacturer Narrative

H11: additional manufacturer narrative: regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.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 coronary artery disease (cad).

Event Description

It was reported that an 21mm 3000 valve, in the aortic position is underwent a valve-in-valve procedure after implant duration of approximately seven (7) years due to severe insufficiency and stenosis with mild perivalvular leak.The patient presented with acute on chronic heart nyha class iii.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
• Type of Device: 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: 18784389
• MDR Text Key: 336289290
• Report Number: 2015691-2024-01341
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300021MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 78 YR
• Patient Sex: Male