EDWARDS INTUITY ELITE VALVE SYSTEM 8300AB

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 EDWARDS INTUITY ELITE VALVE SYSTEM 8300AB manufactured by Edwards Lifesciences.

Event Text Entries

[188405268] The device was returned to edwards for evaluation. Evaluation is in progress. The device history record (dhr) 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. Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus. While the majority of affected patients are asymptomatic, it can lead to significant morbidity including heart failure and hemolytic anemia. Pvl can occur in the mitral and aortic position for similar reasons, including technique and patient related factors. The type and cause of regurgitation varies depending upon multiple factors. Typically, mild regurgitation is not unusual after initial valve replacement, and is usually tolerated by patients. Often moderate to high regurgitation requiring re-operation in the immediate post-operation period is due to procedural related issues and is unrelated to the device. Regurgitation which develops progressively over time can be due to number of issues including patient related factors or structural valve deterioration. A manufacturing issue was not identified. A definitive root cause could not be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event. Edwards lifesciences will continue to monitor all reported events. No further actions are required at this time.
Patient Sequence No: 1, Text Type: N, H10


[188405269] Edwards received information that a 21mm aortic valve, implanted approximately one (1) year, was explanted due to paravalvular leak. The device was originally implanted for aortic valve replacement to correct aortic stenosis. After implant, mild paravalvular leak was detected. The patient had been monitored, but the condition has not been improved. The device was explanted and replaced with a 23mm aortic valve with no adverse patient events reported. Upon the valve explant, paravalvular leak from the area between corresponds to the right-coronary cusp and the non-coronary cusp was detected. The surgeon commented that the encroachment of host tissue on that area was insufficient and thin. The patient status was reported as? Under treatment.? There was no allegation of device malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2015691-2020-11238
MDR Report Key9903631
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-06
Date of Event2020-03-06
Date Mfgr Received2020-03-06
Device Manufacturer Date2017-08-24
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 Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer G1EDWARDS LIFESCIENCES LLC
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEDWARDS INTUITY ELITE VALVE SYSTEM
Generic NameTISSUE, HEART-VALVE
Product CodeLWR
Date Received2020-03-31
Returned To Mfg2020-03-12
Model Number8300AB
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer Address1 EDWARDS WAY IRVINE CA 92614 US 92614


Patients

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

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