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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
Model Number 1104
Device Problems Increase in Suction (1604); Pumping Problem (3016)
Patient Problems Tachycardia (2095); Hypovolemia (2243)
Event Date 10/13/2020
Event Type  Injury  
Manufacturer Narrative
This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation. Product event summary: the ventricular assist device (vad) (b)(4) was not returned for evaluation. Log file analysis associated with (b)(4) revealed one (1) low flow alarm logged on (b)(6) 2020. No suction events were observed within the analyzed period. Log file analysis associated with (b)(4) revealed that the controller was not in use within the analyzed period and was likely the patients backup controller. As a result, the reported low flow events was confirmed; the reported suction event could not be confirmed. Information received from the site indicated that the patient experienced a decrease in circulating blood volume which lead to a suction event which lead to persistent ventricular tachycardia (vt) and the vad exhibited a low flow alarm. An electrocardiogram was performed and the patient was treated with defibrillation and fluid replacement. Based on the available information, the device may have 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, cardiac arrhythmia is a known potential complication associated with the implantation of a vad. Based on review of past adverse events for this patient, it was noted that the patient had a history of cardiac arrhythmia. 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. 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 patient experienced a decrease in circulating blood volume which lead to a suction event which lead to persistent ventricular tachycardia (vt) and the vad exhibited a low flow alarm. An electrocardiogram was performed and the patient was treated with defibrillation and fluid replacement. The vad speed was decreased and the vad remains in use. No further patient complications have been reported as a result of this 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 Key14550228
MDR Text Key293087358
Report Number3007042319-2022-05275
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Date Manufacturer Received10/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2019
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: 05/31/2022 Patient Sequence Number: 1
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