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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 Problems Obstruction of Flow (2423); Pumping Problem (3016)
Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Event Date 06/05/2022
Event Type  Death  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional products: heartware ventricular assist system ¿ outflow graft: model #: 1125 / catalog #: 1125 / expiration date: 28-feb-2023 / serial or lot#: (b)(4); udi #: (b)(4); device available for evaluation: no. Device evaluated by mfr: no, device evaluation anticipated, but not yet begun. Mfg date: 01-feb-2018. Labeled for single use: no. (b)(4). 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 patient was admitted to the hospital with symptoms from an ischemic stroke. The ventricular assist device (vad) flows were initially low, and that was followed by a period of abnormally high power. The patient's lactate dehydrogenase (ldh) was elevated throughout. A computerized tomography angiography (cta) scan revealed a possible thrombus or biological debris in the distal portion of the outflow graft. The patient was not a candidate for thrombolytics due to their neurological status. After continued neurological decline, the patient was transferred to comfort care. The patient subsequently expired, and the official cause of death was reported as stroke.
 
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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 Key14842640
MDR Text Key294858559
Report Number3007042319-2022-05549
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707002639
UDI-Public00888707002639
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,Followup
Report Date 08/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2018
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: 06/28/2022 Patient Sequence Number: 1
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