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

Model Number 3300TFX

Device Problems Perivalvular Leak (1457); Insufficient Information (3190)

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

Event Date 06/08/2023

Event Type  Injury  

Event Description

It was learned through implant patient registry that a 25mm 3300tfx aortic valve was explanted after an implant duration of nine years, six months due to unknown reason.The replacement valve is a 23mm 11500a aortic valve.

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.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.

Manufacturer Narrative

Engineering evaluation summary: per drm (b)(4), rev d, device dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of inadequate device implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.Valve dehiscence is not a malfunction of the device.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.All pertinent information available to edwards lifesciences has been submitted.

Event Description

It was learned through implant patient registry and investigation that a 25mm 3300tfx aortic valve was explanted after an implant duration of nine (9) years, six (6) months and 18 days due to valvular prosthetic dehiscence.The patient presented with heart failure and shortness of breath.The replacement valve is a 23mm 11500a aortic valve.The patient was stable and in recovery at the end of the procedure.Per physician's response, the reason for intervention was due to valvular prosthetic dehiscence (negative blood cultures).

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.Engineering evaluation summary: attempts have been made to obtain missing information; however, to date, no response has been received.Since there is no information regarding an allegation of a device malfunction, an engineering evaluation is not required.Based on the information available, a definitive root cause cannot be conclusively determined.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 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: 17595907
• MDR Text Key: 321646979
• Report Number: 2015691-2023-15396
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2023

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: 08/12/2017
• Device Model Number: 3300TFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 10/06/2023; 11/07/2023
• Supplement Dates FDA Received: 10/16/2023; 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2013
• 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: 75 YR
• Patient Sex: Male