• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problem Failure to Pump (1502)
Patient Problems Syncope (1610); Thrombus (2101); Dizziness (2194); Heart Failure (2206); Hypovolemia (2243)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
This device is used for treatment not diagnosis. The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure. The system is designed for in-hospital and out-of-hospital settings. Product event summary: a pump and controller with unknown serial numbers were not returned for evaluation. Review of the controller log files could not be conducted since log files were not available. As a result, the reported "double disconnect" event could not be confirmed. There is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event. A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one power source. Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course. There are possible patient, pharmacological and procedural factors that may have contributed to this event. Additional products: brand name: heartware ventricular assist system ¿ controller. Model #: unk, catalog #: unk, expiration date: unk, serial #: unk, udi #: (b)(4). Device available for evaluation: no. Mfg date: unk. Labeled for single use: no. (b)(4). This event was reported in the q4 2019 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event. Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was hospitalized with syncope, hypovolemia, heart failure, and concerns for ventricular assist device (vad) thrombus. The patient had been feeling dizzy for one week or so. The patient subsequently passed out. Interrogation of the vad revealed vad stops and losses of power associated with double power disconnects. It was reported that the patient often stopped coumadin despite instructions per vad coordinator. Computed tomography angiogram (cta) of chest did not reveal evidence of thrombosis. The patient was given anticoagulation therapy intervention. The vad was exchanged. The controller remains in use. No further patient complications were reported as part of the event. This event was reported in the q4 2019 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event. Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Type of DeviceVENTRICULAR (ASSIST) 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 Key9880023
MDR Text Key196432608
Report Number3007042319-2020-02705
Device Sequence Number1
Product Code DSQ
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2020
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: 03/25/2020 Patient Sequence Number: 1
-
-