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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
Device Problems Pumping Problem (3016); Noise, Audible (3273)
Patient Problems Hemolysis (1886); Thromboembolism (2654); Thrombosis/Thrombus (4440)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Product event summary: a pump with unknown serial number was not returned for evaluation. The reported high power and abnormal sounds event was not confirmed via review of the controller log files since log files covering the reported event date were not available for analysis. Of note, it was reported that the patient was given anticoagulation intervention therapy. There is no evidence to suggest that a device malfunction caused or contributed to the reported event. Based on the available information and historical review of similar events, the most likely root cause of the high power and abnormal sound event may be attributed to thrombus formation/ingestion. Per the instructions for use, thrombus is a known potential complication associated with the implantation of a vad. Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course. There are possible patient, pharmacological and procedural factors that may have contributed to this event. This event was reported in the q2 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event. Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event. Investigation of this event is completed and the file will be closed. If new information is received, the file will be re-opened and a supplemental will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was admitted with ventricular assist device (vad) high flows and high power alarms. The patient stated that he was in his usual state of health when he started hearing an abnormal sound from his vad. The patient had elevated ldh levels, hemolysis, and an arterial non cns thromboembolism. It was reported that the patient was in a prothrombotic state and the patient was given anticoagulation intervention therapy. The patient underwent a vad exchange. No further patient complications were reported as part of the event. This event was reported in the q2 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event. Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key12656334
MDR Text Key277130210
Report Number3007042319-2021-06686
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 10/19/2021 Patient Sequence Number: 1
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