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

Model Number 7300TFX

Device Problems Perivalvular Leak (1457); Insufficient Information (3190); Central Regurgitation (4068)

Patient Problems Chest Pain (1776); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 01/08/2024

Event Type  Injury  

Event Description

It was reported that a patient with a 29mm mitral valve is being evaluated for a valve-in-valve procedure after an implant duration of 3 years, 8 months due to unknown reasons.

Manufacturer Narrative

Surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned for evaluation, as it remains implanted.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

H10: additional narratives: updated b5, b7, and h6 per new information received.

Event Description

It was reported that a patient with a 7300tfx 29mm mitral valve is being evaluated for a valve-in-valve procedure after an implant duration of 3 years, 8 months due to worsening regurgitation and moderate-to-severe perivalvular leak.The patient presented with nyha class iii, sob, and chest pressure.

Event Description

It was reported that a patient with a 7300tfx 29mm mitral valve underwent a valve-in-valve procedure after an implant duration of 3 years, 8 months due to worsening regurgitation and moderate-to-severe perivalvular leak.The patient presented with nyha class iii, sob, and chest pressure.A 29mm 9600tfx was implanted successfully.

Manufacturer Narrative

A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18624949
• MDR Text Key: 334340800
• Report Number: 2015691-2024-00721
• 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,Followup
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2023
• Device Model Number: 7300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/02/2024; 02/27/2024
• Supplement Dates FDA Received: 02/27/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2019
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male