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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST DEVICE (HVAD) SYSTEM VENTRICULAR (ASSIST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST DEVICE (HVAD) SYSTEM VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pneumonia (2011); Septic Shock (2068); Tachycardia (2095)
Event Date 05/12/2022
Event Type  malfunction  
Event Description
Adult woman with past medical history of icm (ischemic cardiomyopathy) s/p hvad (~1. 5 years ago), turner syndrome, esrd (end-stage renal disease) on pd (peritoneal dialysis), pad (peripheral artery disease) c/b (complicated by) (right) foot gangrene s/p (right) tma (transmetatarsal amputation), t2dm (type 2 diabetes), (right) occipital cva (cerebrovascular accident) with (right) eye ischemia s/p enucleation who presented to hospital after 2 icd (implantable cardioverter defibrillator) shocks at home and was found to be hyperkalemic. During the course of her admission, she developed a bacterial pneumonia and developed septic shock. She was treated for this bacterial pneumonia and had largely stabilized except for working with pt/ot (physical/occupational therapy) and titrating her anticoagulation, which she was very sensitive to. Unfortunately, she had a peri-code event requiring intubation, pressors, and cvicu (cardiovascular intensive care unit) transfer. Ct imaging revealed sdh (subdural hematoma) and iph (idiopathic pulmonary hemosiderosis) with mass effect, neurosurgery recommended repeat nccth (non-contrast ct scan of the head) and medical management. At midnight of next day, patient developed vt (ventricular tachycardia) storm and required several interventions in a peri-code lasting 4 hours. Radiology attending overread of repeat nccth demonstrated slightly increased hemorrhage with new supratentorial and infratentorial herniation. Clinical exam was worrisome for no brainstem reflexes. Brain death testing was equivocal, but prognosis was very poor with patient on several life-sustaining iv medications, ventilator in addition to the hvad and peritoneal dialysis. After a family discussion with the neurology team, the decision was made to made patient partial dnr and withdraw care. The aicd (automatic implantable cardioverter-defibrillator) was turned off, the lvad (left ventricular assist device) was turned off, followed by the drips and the ventilator.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST DEVICE (HVAD) SYSTEM
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
MDR Report Key14435972
MDR Text Key292046382
Report Number14435972
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/13/2022
Event Location Hospital
Date Report to Manufacturer05/19/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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