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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 Problems Obstruction of Flow (2423); Pumping Problem (3016)
Patient Problems Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Event Date 06/15/2022
Event Type  Injury  
Event Description
A journal article was reviewed which contained information regarding ventricular assist devices (vads). The article discussed a single german medical center¿s experience with changing thrombolysis protocols and reported clinical outcomes. Multiple patients were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers. There were patients on vad support who experienced pump thromboses. They were hospitalized with heart failure symptoms with the pumps exhibiting low flow with increased power consumption and pulsatility. The patients underwent laboratory and imaging diagnostic workups and most underwent intravenous (iv) thrombolytic therapy with resolution. Twenty-two patients encountered pump stops, outflow graft thromboses, inflow cannula thromboses, ineffective thrombolysis or had co-morbidities contraindicating thrombolytic therapy, so underwent surgical pump exchanges or urgent heart transplantation instead. The vads remain in use. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific de vice information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Multiple patients were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers. The baseline gender/age of the pediatric patients represented in the article is male/53 years old. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. Request for additional information will be made and, upon receipt, a supplemental report will be submitted accordingly. Referenced article: fox h. ; et al. Evolution of thrombolytic therapy in patients with heartware ventricular assist device thrombosis: a single-institutional experience. Interact cardiovasc thorac surg. (b)(6) 2022 15;35(1). Pii: 6540697. Doi: 10. 1093/icvts/ivac054. Pmid: 35234899. Additional information has been requested regarding the cause of the events, device serial numbers and patient demographic data, but it was not available at the time of this report. If additional information is received, the event will be updated and a supplemental report will be sent. Investigation of this event is pending and a supplemental report will be sent upon its completion. 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 Key15126137
MDR Text Key296845450
Report Number3007042319-2022-06747
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/26/2022
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: 07/28/2022 Patient Sequence Number: 1
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