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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 Problem Pumping Problem (3016)
Patient Problems Pain (1994); 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 low flow 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 underwent surgical and anticoagulation intervention. There is no evidence to suggest that a device malfunction caused or contributed to the reported event. Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed. Per the instructions for use, this event 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 hospitalized after the ventricular assist device (vad) lost all flow for approximately 2 hours with a power of 1. 7 as a result of thrombus. The controller was switched per surgeon's orders and the vad was restarted to baseline flows. Shortly after the vad was restarted, the patient experiencing left lower leg pain and loss of sensation as a result of an arterial non cns thromboembolism. Pulses were lost as well. The patient underwent surgical and anticoagulation intervention. The patient received a heart transplant. 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 Key12656497
MDR Text Key277150101
Report Number3007042319-2021-06687
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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