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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 Dyspnea (1816); Pleural Effusion (2010); Weight Changes (2607); Unspecified Vascular Problem (4441); Heart Failure/Congestive Heart Failure (4446); Peripheral Edema (4578)
Event Date 09/10/2020
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 mechanical circulatory support product surveillance registry study. Product event summary: the ventricular assist device (vad) hw40121 was not returned for evaluation. This complaint is associated with a clinical adverse event. Information received from the site indicated the patient experienced shortness of breath and stridor. They were admitted with swelling bilateral lower extremities and their weight was increased. A chest x-ray showed cardiomegaly with modulated vascular congestion. The patient also experienced congestive heart failure and a small right pleural effusion. They received an intravenous (iv) antidiuretic and a limited echo was planned. Based on the available information, the device may have caused or contributed to the reported event. Per the instructions for use, worsening heart failure, pleural effusion and respiratory dysfunction 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. 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. Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the ventricular assist device (vad) patient experienced shortness of breath and stridor. They were admitted with swelling bilateral lower extremities and their weight was increased. A chest x-ray showed cardiomegaly with modulated vascular congestion. The patient also experienced congestive heart failure and a small right pleural effusion. They received an intravenous (iv) antidiuretic and a limited echo was planned. 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 Key15093995
MDR Text Key296487653
Report Number3007042319-2022-06694
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
Reporter Occupation
Type of Report Initial
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2020
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/31/2018
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: 07/25/2022 Patient Sequence Number: 1
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