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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM

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HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM Back to Search Results
Catalog Number 1101
Event Date 12/18/2012
Event Type  Death  
Event Description

This event involved a patient that was found unresponsive by a family member approximately 4 years post implant. The controller was alarming which continued after the controller was exchanged. Emergency medical services (ems) arrived and confirmed that the patient was unresponsive. The patient was admitted to the local emergency room where he was pronounced dead. A partial autopsy was performed in order to remove the device. While explanting the pump, a clot was found.

 
Manufacturer Narrative

The product was returned; various analyses were conducted and reviewed in order to evaluate the performance of the lvad pump in relation to the reported event. This included clinical evaluation, review of manufacturing documentation, labeling and instructions for use, visual and functional examination, independent pathology analysis and review of controller log files. Review of the controller log files show a sudden drop in flow and power, concurrent with the time of death. Independent pathological analysis did not confirm the presence of thrombus within the device. Clinical factors that may have contributed to this event include the patient's recent and past medical history of severe refractory nyha class iv heart failure, ventricular arrhythmias, icd and lvad placement. Review of the manufacturing documentation confirmed that (b)(4) met all requirements for release. Post-explant engineering evaluation did not reveal any conditions that would have contributed to the reported event. The root cause of the patient's death in this case cannot be conclusively determined. Based on review of the available information, there is no evidence to suggest that the reported event relates to a device defect. No additional information will be forthcoming.

 
Manufacturer Narrative

Additional information will be submitted within thirty (30) days of receipt.

 
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Brand NameHEARTWARE® VENTRICULAR ASSIST SYSTEM
Type of DeviceCIRCULATORY ASSIST SYSTEM
Manufacturer (Section D)
HEARTWARE, INC
14420 nw 60th avenue
miami lakes FL 33014 310
Manufacturer (Section G)
HEARTWARE, INC
14420 nw 60th avenue
miami lakes FL 33014 310
Manufacturer Contact
miguel sosa
14420 nw 60th avenue
miami lakes , FL 33014-3105
3053641555
MDR Report Key2920441
Report Number3007042319-2013-00001
Device Sequence Number1
Product CodeDSQ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 12/19/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date04/30/2009
Device Catalogue Number1101
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/21/2012
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/19/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/25/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/17/2013 Patient Sequence Number: 1
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