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); Device Dislodged or Dislocated (2923); Thickening of Material (4056)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 10/24/2023

Event Type  Injury  

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 Description

Through the records of (b)(4) it was learned that a 25mm 7300tfx was explanted after an implant duration of 8 years and 1 month due too dehiscence, severe large paravalvular regurgitation, and thicken leaflets.The explanted valve was replaced with a non-edwards mitral valve.Per medical records, the patient presented with heart failure nyha ii, and underwent a redo avr and mvr, tvr (severe regurgitation), and maze procedure.Intraoperatively the 19mm 3300tfx valve ((b)(4)) had a large amount of pannus underneath the valve which was excised, the leaflets were thickened.The aortic root was too small, trying to put a 21mm would have obstructed the coronary, so a 19mm 11500a was implanted and considered good for her bsa.The 25mm 7300tfx ((b)(4)) had dehiscence on the posteromedial aspect and it was very clear that the stitches on the posteromedial side had cut through the annulus.The leaflets were thickened.The mitral valve was replaced with a 27mm nonedwards ( st jude epic) valve.The tricuspid repair was performed with a 30mm mc3 annuloplasty ring.Patient transferred to the cvicu post-op.On pod #10, the patient discharged home in stable condition with 81mg aspirin qd, and eliquis qd for 30 days.

Manufacturer Narrative

The device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Device dehiscence or suture torn out may occur early or late.When it occurs in the intraoperative period, it is typically a result of inadequate device implantation in combination with friable myocardial tissue.Valve dehiscence is not a malfunction related to a manufacturing deficiency of the device.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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18436782
• MDR Text Key: 331865225
• Report Number: 2015691-2024-00024
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2019
• Device Model Number: 7300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2015
• 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; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female