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 01/26/2024

Event Type  Injury  

Event Description

It was learned through implant patient registry that a patient with a 27mm 7300tfx mitral valve was explanted after an implant duration of 3 years, 9 months due to unknown reason.The explanted valve was replaced with a 33mm 11400m valve.The patient was in recovery post procedure.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.

Manufacturer Narrative

Intermediate, or late endocarditis (greater than 60 days post-implant) occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the patient's body and is not in any way related to the sterilization or packaging process of the device.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

It was learned through implant patient registry and investigation that a patient with a 27mm 7300tfx mitral valve was explanted after an implant duration of 3 years, 9 months due to streptococcus mitis endocarditis with dehiscence, pvl, and severe insufficiency.The explanted valve was replaced with a 33mm 11400m valve.Per medical records, the patient presented with flu like symptoms.Work-up revealed multiple small acute embolic infarcts, strep mitis, and vegetation on the mitral leaflets following dental procedure.The patient underwent a redo mvr with reconstruction of the mitral annulus.Intraoperative finds showed dehisced valve with a large paravalvular leak and vegetations.The valve was excised.After annular debridement a 33mm mitris valve was implanted and secured with cor-knots.The valve was tested and was competent with no pvl.The patient tolerated the procedure and transferred to icu in critical condition.

• 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: 18822394
• MDR Text Key: 336733622
• Report Number: 2015691-2024-01535
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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
• Date Manufacturer Received: 03/04/2024
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male