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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE LVAD; VENTRICULAR ASSIST BYPASS
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HEARTWARE LVAD; VENTRICULAR ASSIST BYPASS Back to Search Results
Device Problems Defective Alarm (1014); Pumping Stopped (1503); Device Stops Intermittently (1599); Device Inoperable (1663)
Patient Problems Death (1802); Pain (1994); Thrombus (2101); Multiple Organ Failure (3261)
Event Date 03/25/2016
Event Type  Death  
Event Description
My husband had a heart ware lvad, he received bivads in a (b)(6) hospital in 2014.Over the course of those 2 years he was admitted to the hospital numerous times for complications related to his congestive heart failure diagnosis.At some point the right vad clotted but fortunately for my husband the right lvad was no longer needed because his heart had recovered enough to support itself.This gave my husband a renewed hope for a full recovery or at least a chance to hopefully receive a heart transplant.In (b)(6) 2016 the left lvad suddenly and abruptly stopped working, without any warnings or alarms from his controller.Surgeons attempted to replace the pump but were unsuccessful and he died.I am devastated, my husband nor i were never told that these pumps could malfunction without warning.My husband suffered because this pump stopped working causing organ failure and pain.
 
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Brand Name
LVAD
Type of Device
VENTRICULAR ASSIST BYPASS
Manufacturer (Section D)
HEARTWARE
MDR Report Key6360605
MDR Text Key68481478
Report NumberMW5068122
Device Sequence Number1
Product Code DSQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/24/2017
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 No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/24/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age46 YR
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