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

Model Number 7300TFX

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

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

Event Date 12/15/2023

Event Type  Injury  

Event Description

It was learned through implant patient registry that a patient with a 29mm 7300tfx mitral valve was explanted after an implant duration of 4 months, 4 days due to unknown reason.The explanted valve was replaced with a 31mm 7300tfx 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

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 and investigation that a patient with a 29mm 7300tfx mitral valve was medically treated for chlamydia pneumoniae infective endocarditis/vegetation with severe paravalvular regurgitation after implant duration of approximately 1 month.The valve was explanted after a implant duration of 4 months due to continued endocarditis and dehiscence.The valve was replaced with a 31mm 7300tfx valve.Per medical records, the patient presented with infective endocarditis, initial echo showed mitral valve rocking, small mobile mass on anterior/posterior leaflets consistent with vegetation, and severe pvl.History of iv drug abuse and noncompliance.The patient was discharged with 6 weeks of doxycycline for chlamydia pneumoniae.He was re-admitted approximately 2 months later, presented with exacerbation of chf and mitral valve was found to have dehisced.Consider non-compliance vs resistance as cause for increased titers.The patient underwent redo mvr with bovine pericardium patch reconstruction of the annulus.A 31mm 7300tfx was implanted and secured with cor-knots.The chest was left open due to coagulopathy, and he was transferred to the icu in stable condition.Per id doctor, completed a course iv ceftriaxone, continue on doxycycline po at least 6 months after cardiac surgery, consider lifelong therapy.The patient was discharged on pod #18.

Manufacturer Narrative

Per edwards microbiology report, chlamydia pnuemoniae organism is predominantly from respiratory infection and the sealed package containing this bioprosthetic valve was not the source of infection.H11 corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• 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: 18681397
• MDR Text Key: 335069470
• Report Number: 2015691-2024-00916
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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 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: 01/15/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male