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

Model Number 3300TFX

Device Problems Degraded (1153); Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190); Device Stenosis (4066)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2023

Event Type  Injury  

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.

Event Description

It was learned through implant patient registry that a 23mm 3300tfx aortic valve was explanted after an implant duration of 5 years, 5 months due to unknown reason.The explanted valve was replaced with a 25mm 11500a valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional 'customer complaint'.The information reported may or may not be related to the edwards device.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections d4 (expiration date, udi number), h4, h6 (component code, device codes, type of investigation, investigation findings, investigation conclusions).H10: additional manufacturer narrative: 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.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, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction.The root cause of this event cannot be conclusively determined with the available information.However, this event is likely impacted by the progression of the patient's underlying valvular disease pathology with structural valve deterioration.The subject device is not available for evaluation.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.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

It was learned through implant patient registry and investigation that a 23mm 3300tfx aortic valve was explanted after an implant duration of 5 years, 5 months due to moderate structural disruption and symptomatic severe stenosis.The explanted valve was replaced with a 25mm 11500a valve.Per medical records, the patient underwent redo avr and closure of asd x2.Intraoperatively the aortic valve was inspected and found to be relatively normal, suggestive of patient prosthesis mismatch given the patient's gradient.Findings was noted as moderately diseased prosthetic valve.The annulus was debrided and sized to a 25mm 11500a valve.The new valve was implanted and confirmed to be well-seated.Post cpb tee showed the valve was functioning properly and no major perivalvular leaks were identified.The patient was taken in critical, but stable condition to the sicu.Per hospital pathology report, final diagnosis was prosthetic aortic valve with moderate structural disruption.Gross examination: two of the leaflets attached and mobile.Calcification and vegetation are grossly absent.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA 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: 18332041
• MDR Text Key: 330548249
• Report Number: 2015691-2023-18387
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103176148
• UDI-Public: (01)00690103176148(17)220226
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S042
• 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
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male