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

Model Number 3300TFX

Device Problems Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Insufficient Information (4580)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation, as it remains implanted in the patient.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 reported, that a patient with a 25mm 3300tfx aortic valve underwent a valve-in-valve procedure.After an implant duration of 8 years and 2 months, due to unknown reasons.The procedure was performed successfully with a 26mm 9750tfx transcatheter valve.The patient post procedure in recovery.

Manufacturer Narrative

The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Prosthetic endocarditis is a serious complication of valve replacement and repair surgeries despite improvements in prosthesis types, surgical techniques, and infection control measures.This infection is categorized into early (onset at 60 days or less post-implant) and intermediate/late (onset greater than 60 days post-implant).Intermediate/late onset occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body and is not related to the sterilization or packaging process.In this case the onset was greater than 60 days post-implant.The most likely cause is patient factors.H11 corrected data: based on the new information received, this event is no longer considered reportable.

Event Description

It was reported and learned through investigation that a patient with a 25mm 3300tfx aortic valve underwent a valve-in-valve procedure after an implant duration of 8 years and 2 months due to streptococcus viridans endocarditis with stenosis.The patient presented with shortness of breath and lightheadedness.The procedure was performed successfully with a 26mm 9750tfx transcatheter valve.The patient was in stable conditions post procedure.

• 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: 17312022
• MDR Text Key: 318922520
• Report Number: 2015691-2023-14524
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103176155
• UDI-Public: (01)00690103176155(17)180907
• 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: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2018
• Device Model Number: 3300TFX
• Device Catalogue Number: 3300TFX25MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2014
• 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; Hospitalization; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Male