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

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

  • 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
 

THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM Back to Search Results
Model Number 106524INT
Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 05/18/2018
Event Type  Injury  
Manufacturer Narrative
Approximate age of device ¿ 2 years and 1 month. (b)(6). Abbott has decided to initiate a voluntary field action for all lot numbers of heartmate iii distributed since september 2014. Internal investigation performed by abbott has determined there is a potential for an outflow graft occlusion due to twisting. Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. The root cause identification determined that bend relief rotation is inconsistently translated to the outflow graft hardware. A risk/benefit analysis was performed and it was determined that despite the potential for an outflow graft occlusion due to twisting, the associated residual risks are low and are considered acceptable. As a corrective action, consignees have been notified of the potential occlusion due to twisting. Additionally, abbott will continue to trend complaints related to this event based on original event description and/or results of product evaluation. The lvad remains implanted in the patient but is not in use. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016. It was reported that on (b)(6) 2018, a re-exploration of the lvad was performed due to frequent low flow alarms despite optimization of treatment. During re-exploration, a twist at the end of the outflow graft was found. After de-rotation of the outflow graft, the pump parameters normalized. The patient was reportedly stable and doing well. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
Type of DeviceLEFT VENTRICULAR ASSIST SYSTEM
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key7588643
MDR Text Key110677783
Report Number2916596-2018-02160
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeLS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model Number106524INT
Device Catalogue Number106524INT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberZ-1774-2018

Patient Treatment Data
Date Received: 06/11/2018 Patient Sequence Number: 1
-
-