• 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 - OUTFLOW GRAFT 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 - OUTFLOW GRAFT VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284); Misassembly by Users (3133); Material Split, Cut or Torn (4008)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 06/18/2019
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. Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific device 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 the u. S. All information provided is included in this report. Patient information is limited due to confidentiality concerns. A one to one correlation could not be made with unique device serial numbers. 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: early postoperative rupture of heartware outflow graft: a case report. Journal of cardiac surgery, august 2019; 34(8):742-744. Doi: 10. 1111/jocs. 14120. 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 discussed a case report of post-operative outflow graft rupture. One patient's post-operative course was complicated by the development of surgical site bleeding. The patient was taken back to the operating room and underwent re-sternotomy, wherein intensive mediastinal hemorrhage was discovered. Bleeding was isolated to a rupture at the junction of the outflow graft with the pump. The graft was exchanged. The article notes the rupture was a perforation of the graft caused by squeezing/crushing of the graft material between the clamp and connection point to the pump outlet, possibly occurring during assembly in surgery. The status/location of the vad is unknown. No further patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT
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 Key9154012
MDR Text Key161714138
Report Number3007042319-2019-12028
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2058-2020

Patient Treatment Data
Date Received: 10/03/2019 Patient Sequence Number: 1
-
-