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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 1103
Device Problem Increase in Suction (1604)
Patient Problems Dyspnea (1816); Pleural Effusion (2010); Respiratory Failure (2484); Hypervolemia (2664)
Event Date 07/05/2020
Event Type  Injury  
Event Description
It was reported that the patient was admitted for symptomatic shortness of breath and respiratory dysfunction. A computerized tomography (ct) scan showed pleural effusions possibly related to fluid overload. A right heart catherization (rhc) was performed and echocardiogram was unremarkable. The patient was diuresed and given antibiotics, then taken to interventional radiology (ir) for a pigtail placement. The ventricular assist device (vad) exhibited suction due to over diuresing and some volume was given back with albumin. The pigtail was removed, and patient was discharged home. The vad remains in use. No further patient complications have been reported as a result of this event.
 
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: (b)(4) was not returned for evaluation. The reported suction event could not be confirmed since log files were not available for analysis. Information provided by the site indicated that, in addition to the suction event, the patient was admitted for symptomatic shortness of breath and respiratory dysfunction. A computerized tomography (ct) scan showed pleural effusions possibly related to fluid overload. It was also reported that the suction event was due to over diuresing and some volume was given back with albumin. Based on the available information, the device may have caused or contributed to the reported event. Per the instructions for use, respiratory dysfunction and pleural effusion are known potential complications associated with the implantation of a vad. There was no evidence that the patient had a history of similar adverse events. Based on risk documentation, multiple factors may have contributed to the suction event 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. 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.
 
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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 Key13415741
MDR Text Key284812149
Report Number3007042319-2022-00414
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707002639
UDI-Public00888707002639
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/21/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/30/2018
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: 02/01/2022 Patient Sequence Number: 1
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