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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS; REPLACEMENT, HEART-VALVE Back to Search Results
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 02/19/2024
Event Type  Injury  
Manufacturer Narrative
The subject device is not available for evaluation, as the device status is unknown at this time.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 patient with a 31mm 7300tfx mitral valve, was explanted after an implant duration of two (2) years, eight (8) months due to unknown reason.The explanted valve was replaced with a 31mm 11400m valve.The patient is noted to be in recovery.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: b5, b7, g3, g6, h2, h6 (component code, clinical code, device code, type of investigation).H11: corrective data: 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 that a patient with a 31mm 7300tfx mitral valve, implanted in the tricuspid position, was explanted after an implant duration of two (2) years, eight (8) months due to recurrent methicillin-sensitive staphylococcus aureus (mssa) endocarditis, vegetation, and severe tricuspid regurgitation.The explanted valve was replaced with a 31mm 11400m valve.The patient tolerated the procedure well and was transferred to the icu in stable condition.On pod #5, the patient was discharged.
 
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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
1 edwards way
irvine CA 92614
Manufacturer Contact
saurav singh
1 edwards way
mle fl2- office m2013
irvine, CA 92614
9492506615
MDR Report Key19052520
MDR Text Key339501251
Report Number2015691-2024-02623
Device Sequence Number1
Product Code DYE
UDI-Device Identifier00690103186284
UDI-Public(01)00690103186284(17)250417
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/23/2024
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 Number7300TFX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received04/05/2024
Supplement Dates Manufacturer Received04/10/2024
Supplement Dates FDA Received04/23/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age25 YR
Patient SexMale
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