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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS COMMANDER DELIVERY SYSTEM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

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EDWARDS LIFESCIENCES LLC EDWARDS COMMANDER DELIVERY SYSTEM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9600LDS29
Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Patient Problems Cardiopulmonary Arrest (1765); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Event Date 07/22/2020
Event Type  Injury  
Event Description
As the device was being deployed, the physician noted that blood was coming back into the indeflator of the valve delivery system.The indeflator was disconnected, and there was noted to be risk, pulsatile bleed back from the delivery system signifying that the tear in the balloon was large.Upon removing the valve and esheath, there was resistance in the iliac artery and the patients blood pressure dropped, cpr was initiated.With removal of the undeployed valve, it was noted that the external iliac artery had avulsed and come out with the valve as it was stuck on the valve.
 
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Brand Name
EDWARDS COMMANDER DELIVERY SYSTEM
Type of Device
PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
MDR Report Key10395252
MDR Text Key202523994
Report Number10395252
Device Sequence Number1
Product Code NPU
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/04/2020
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? Yes
Device Operator Health Professional
Device Model Number9600LDS29
Device Catalogue Number9600LDS29A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/04/2020
Date Report to Manufacturer08/12/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age29200 DA
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