CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS 3300TFX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS 3300TFX manufactured by Edwards Lifesciences.

Event Text Entries

[187856564] Stenosis and/or regurgitation, which develops progressively over time, can be due to a number of issues. Additionally, there can be a number of potential known and unknown patient related contributing factors. Structural valve deterioration (svd), a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these. Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation. Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis and/or regurgitation. Stenosis and/or regurgitation is most commonly related to patient factors, and is not usually an indication of a device malfunction. The device was not returned for evaluation, as it remains implanted. Minimal information regarding this procedure was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful. The root cause of the event remains indeterminable. If new information becomes available, a supplemental report will be submitted. The device history record (dhr) was not able to be reviewed as the device serial number was not provided. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10


[187856565] Edwards received notification that an aortic valve was disabled via a valve-in-valve replacement after an approximate implant duration of 5 years due to stenosis and regurgitation. A non-edwards valve was implanted. The patient was noted as to be recovering after the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2015691-2020-11255
MDR Report Key9908640
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-06
Date of Event2020-02-20
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. AMRITHA SRINIVASAN
Manufacturer StreetONE EDWARDS WAY MLE-2
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492504062
Manufacturer G1EDWARDS LIFESCIENCES LLC
Manufacturer StreetONE EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
Generic NameHEART-VALVE, REPLACEMENT
Product CodeDYE
Date Received2020-03-31
Model Number3300TFX
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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