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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 Adhesion(s) (1695); Pleural Effusion (2010); Thrombosis/Thrombus (4440)
Event Date 01/04/2021
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 pro vided, 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: heartware explant after recovery 6 years after implant in a 3-year-old child: has the game changed? the annals of thoracic surgery, july 2021; 112(1):e37-e39. Doi: 10. 1016/j. Athoracsur. 2020. 10. 061. Epub 2021 jan 4. Pmid: 33412138 additional information has been requested regarding the cause of the event, device serial number and device disposition, 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 the course of vad treatment in a pediatric patient. One patient's post-operative course was complicated by development of a thrombus on the tip of the vad inflow cannula approximately six months after implantation. The patient was noted to have recovered sufficient left ventricular (lv) function to no longer need vad support. The patient was hospitalized and underwent surgery to decommission the vad in situ. Approximately six years after vad placement, a decision was made to explant the vad. It was noted during surgery that tight adhesions were present between the vad and lung tissue. As a result of the dissections needed to mobilize the device, the patient developed a left pleural effusion, requiring post-operative high-flow oxygen support for four weeks. The status of the vad is unknown. No further patient complications have been reported as a result of this event.
 
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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 Key13474791
MDR Text Key289339908
Report Number3007042319-2022-02380
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUK
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 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2022
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: 02/07/2022 Patient Sequence Number: 1
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