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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Bacterial Infection (1735); Thromboembolism (2654)
Event Date 01/01/2021
Event Type  Injury  
Event Description
It was reported that the patient was hospitalized for a major bacterial infection requiring anti-microbial medication, deep vein thrombosis, and sustained ventricular arrhythmia resulting in clinical compromise, or requiring medical intervention. The ventricular assist device (vad) remains in use. No further patient complications have been reported as a result of this event. This event was reported in the q1 2022 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event. Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.
 
Manufacturer Narrative
Product event summary: one (1) pump with unknown serial number was not returned for evaluation. This complaint is associated with a clinical adverse event. Review of the sterility certificate could not be performed since the serial number is unknown. Based on the available information, the device may have caused or contributed to the reported event. Per the instructions for use, this event is a known potential complication 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, the progression of their underlying disease and the patient's complex post-operative course. There are possible patient, pharmacological and procedural factors that may have contributed to this event. This event was reported in the q1 2022 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event. Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the 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.
 
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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 Key14855515
MDR Text Key295112719
Report Number3007042319-2022-06270
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 Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/29/2022 Patient Sequence Number: 1
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