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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446)
Event Date 07/02/2019
Event Type  Death  
Event Description
It was reported that three years post ventricular assist device (vad) implantation, the patient was admitted with symptoms of worsening right heart failure and pleural effusions. The patient was intubated and placed on inotropes, however, the patient¿s status continued to decline. Palliative care was consulted, and the patient¿s spouse decided to withdraw care. An autopsy was not performed, and the patient¿s cause of death was deemed as multi-system organ failure.
 
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: ventricular assist device (vad) (b)(4) was not returned for evaluation. This complaint is associated with a clinical adverse event. Information received from the site indicated that the patient was admitted with symptoms of worsening right heart failure and pleural effusions. The patient was intubated and placed on inotropes; however, the patient¿s status continued to decline. Care was withdrawn, and the patient subsequently expired due to multi-system organ failure. Based on the limited information available, the device may have caused or contributed to the reported event. Per the instructions for use, worsening heart failure, pleural effusion, multi-organ failure, and death are known potential complications 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, 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 is 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 Key13552372
MDR Text Key285773904
Report Number3007042319-2022-02569
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707000017
UDI-Public00888707000017
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 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2018
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/31/2016
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: 02/17/2022 Patient Sequence Number: 1
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