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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1104
Device Problems Pumping Stopped (1503); Pumping Problem (3016); Material Split, Cut or Torn (4008)
Patient Problems Malaise (2359); Unspecified Mental, Emotional or Behavioural Problem (4430); Heart Failure/Congestive Heart Failure (4446)
Event Date 03/22/2021
Event Type  Injury  
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. 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: left ventricular assist device failure requiring percutaneous conduit occlusion with a vascular plug. Jacc: cardiovascular interventions, march 22, 2021; 14(6):e61-e63. Doi: 10. 1016/j. Jcin. 2020. 12. 034. Pmid: 33736789. Additional information has been requested regarding the cause of the event, device serial number 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. 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 was a case report on percutaneous decommissioning of a vad in situ. One patient developed a psychotic episode and transected the driveline causing pump shutdown. The patient was hospitalized with worsening heart failure symptoms and a transthoracic echocardiogram (tte) noted retrograde blood flow through the left vad (lvad) circuit. The patient was deemed ineligible for a pump exchange or heart transplant. Percutaneous/endoscopic closure of the lvad conduit was conducted using a vascular plug. The patient was discharged from the hospital with no noted complications; however the patient was later re-admitted for malaise from medication non-compliance. The vad remains de-activated within the patient. No further patient complications have been reported as a result of this event.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
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 Key13388597
MDR Text Key286448344
Report Number3007042319-2022-00384
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeCA
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,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/11/2018
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: 01/28/2022 Patient Sequence Number: 1
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