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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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EDWARDS LIFESCIENCES LLC INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Device Problems Perivalvular Leak (1457); Positioning Problem (3009)
Patient Problem Failure of Implant (1924)
Event Date 06/12/2020
Event Type  Injury  
Event Description
Patient was scheduled and consented for an aortic valve replacement.Operating surgeon sized his aortic valve annulus appropriately and wanted to implant an edwards 23mm inspiris aortic valve.Upon closure of his aortotomy, he wanted a cardiologist to interpret tee results.The cardiologist interpreted that the current aortic valve was still, "leaking," and it appeared to have mild-moderate intravalvular aortic insufficiency.This valve was explanted and an edwards 23mm perimount valve was implanted in replace.The cardiologist returned to interpret the perimount aortic valve and showed excellent trileaflet motion and no ai was noted.The leaflets of the 23mm inspiris aortic valve appeared to be not flushed with one another and distorted.(strut).This respective valve was placed in a specimen container with ns.The patient progressed well after surgery and was deemed appropriate for discharge on pod #7 to home.Fda safety report id# (b)(4).
 
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Brand Name
INSPIRIS RESILIA AORTIC VALVE
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
irvine CA
MDR Report Key10224064
MDR Text Key197607293
Report NumberMW5095340
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient Weight70
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