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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART-VALVE

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EDWARDS LIFESCIENCES; REPLACEMENT HEART-VALVE Back to Search Results
Device Problem Perivalvular Leak (1457)
Patient Problem Insufficient Information (4580)
Event Date 11/29/2022
Event Type  Injury  
Manufacturer Narrative
Additional narratives: paravalvular leak (pvl) refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.It may occur as a result of a lack of appropriate sealing of the valve at the annulus or improper seating.The most common reason for pvl is inadequate debridement of a calcified annulus and is not a result of device malfunction.There may be small pvls identified intra-operatively or post-operatively which do not require any intervention.Most cases of pvl noted intra-operatively are corrected with standard surgical techniques during the initial implant procedure.The device was not returned for evaluation, as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
 
Event Description
It was reported that a patient with an unknown model aortic valve was scheduled for a valve-in-valve procedure after an unknown implant duration due to perivalvular leak.The procedure was aborted due to patient safety concerns.
 
Manufacturer Narrative
H10: additional narratives: updated h6 per new information received.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.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.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.
 
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Brand Name
NI
Type of Device
REPLACEMENT HEART-VALVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
saurav singh
one edwards way
mle fl2- office m2013
irvine, CA 92614
9492506615
MDR Report Key16016875
MDR Text Key305834383
Report Number2015691-2022-10178
Device Sequence Number1
Product Code DYE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/10/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/29/2022
Initial Date FDA Received12/20/2022
Supplement Dates Manufacturer Received02/09/2023
Supplement Dates FDA Received02/10/2023
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 Number1
Patient Outcome(s) Life Threatening; Hospitalization; Required Intervention;
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