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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 02/15/2013
Event Type  Injury  
Event Description

This event involved a patient who experienced a high power events approximately 2 years and 5 months post heartware lvad implantation. On (b)(6) 2012 the patient presented to the emergency room (er) with brownish urine and low back pain. An echo was performed and it revealed a "pump clot" (thrombus). Patient was transferred to icu where he was administered tpa infusion. A second echo was performed the next day and showed no presence of thrombus. Patient was started on heparin drip. Ldh decreased to 701 u/l. Patient was discharged back home with improved condition (b)(6) 2013. Approximately a month later on (b)(6) 2013, the patient was taken to the emergency room (er) with gross hematuria. The hospital performed an echocardiogram which confirmed a clot in the pump and a kinked outflow graft at a 90° degree angle. Therefore, the patient underwent a pump exchange.

 
Manufacturer Narrative

(b)(6) is also part of the patient identifier. The device is available for evaluation, but has not been received by the manufacturer. Additional information will be submitted within thirty (30) days of receipt.

 
Manufacturer Narrative

(b)(6) is also part of the patient identifier. 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. Deformation of the outflow graft was confirmed during gross pathological evaluation. The root cause of the kink in the outflow graft could not be conclusively determined. Pathological analysis did show thrombus formation consistent with the acute event (patient taken to the er with gross hematuria) that occurred at or around the time of (b)(6) 2013 exchange. Clinical factors that may have contributed to the suspected thrombus formation include episodes of infection and history of right ventricular dysfunction as reported by the site. Review of the manufacturing documentation confirmed that hw888 met all requirements for release. Post explant engineering evaluation did not reveal any conditions that would have contributed to the reported event. Based on the information provided, there is no evidence to suggest that the reported event relates to a device defect. No additional information will be forthcoming.

 
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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 Key3012728
Report Number3007042319-2013-00036
Device Sequence Number1
Product CodeDSQ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/18/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date05/31/2011
Device Catalogue Number1101
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/07/2013
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/18/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/10/2010
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: 03/20/2013 Patient Sequence Number: 1
Treatment
COUMADIN
AMLODIPINE
DIFLUCAN
ASPIRIN 325
TPA
CEPHALEXIN
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