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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 UNK-PUMP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Hypovolemic Shock (1917); Septic Shock (2068); Respiratory Failure (2484); Multiple Organ Failure (3261); Heart Failure/Congestive Heart Failure (4446)
Event Date 02/05/2021
Event Type  Death  
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. This event occurred outside of the u. S. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Multiple patients and multiple manufacturers 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 patients represented in the article is male/ (b)(6) years old. The dates of death are not available at the time of this report as there is no indication of specific serial number/patient information. 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: impact of a surgical approach for implantation of durable left ventricular assist devices in patients on extracorporeal life support. Journal of cardiac surgery, april 2021;36(4):1344-1351. Doi: 10. 1111/jocs. 15401. Pmid: 33547707. Investigation of this event is pending and a supplemental report will be sent upon its completion. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was reviewed which contained information regarding ventricular assist devices (vads). The article compared clinical outcomes between full sternotomy versus less-invasive implantation techniques in left vad (lvad) patients who required pre-operative extracorporeal membrane oxygenation (ecmo). The data was based upon the ecls-vad european multi-center clinical registry. Multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers. The article reports patient deaths while on vad support, due to multiple organ dysfunction syndrome (mods), septic shock, strokes, heart failure, hemorrhagic shock and respiratory failure. The status of the vads is unknown.
 
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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 Key12866880
MDR Text Key281191331
Report Number3007042319-2021-08162
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,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK-PUMP
Device Catalogue NumberUNK-PUMP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2021
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: 11/24/2021 Patient Sequence Number: 1
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