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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 Pain (1994); Thromboembolism (2654)
Event Date 08/03/2020
Event Type  Injury  
Manufacturer Narrative
This regulatory report is being submitted as part of a retrospective review and remediation per d00700870. This information was received from the psr mcs therapy base. Product event summary: ventricular assist device (vad) hw41514 was not returned for evaluation. This complaint is associated with a clinical adverse event. Information received from the site indicated that the patient experienced pain in the area of their right upper extremity and had a duplex venous scan performed which revealed a non-occlusive superficial venous thrombus in the right basilic vein. Based on the limited information available, the device may have caused or contributed to the reported event. Per the instructions for use, venous thromboembolism is a known potential complication associated with the implantation of a vad. There was no evidence that the patient had a history of similar adverse events. 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 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.
 
Event Description
It was reported that approximately four months post ventricular assist device (vad) implantation, the patient had a duplex venous scan performed on their right upper extremity due to patient experiencing pain in the area. The scan revealed a non-occlusive superficial venous thrombus in the right basilic vein. Of note, no action was taken at the time due to the patient already being on anticoagulation medication. 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 Key15032253
MDR Text Key296007194
Report Number3007042319-2022-06585
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 Study,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2021
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/02/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/05/2019
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: 07/15/2022 Patient Sequence Number: 1
Treatment
6935M55 LEAD, DDMB1D4 ICD, 5076-45 LEAD
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