• 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 106524
Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/23/2018
Event Type  malfunction  
Manufacturer Narrative
Approximate age of device - 1 year. The patient remains ongoing with the device. 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) 2017. It was reported that the lvad system was producing low flow alarms. The patient was admitted to the hospital, an echocardiogram was performed and showed the atrioventricular (av) opens with every beat. The patient was discharged. On (b)(6) 2018, the patient returned to operating room (or) and a twist in the outflow graft was found. A surgical procedure was performed to untwist the graft. The patient was stable after the procedure. No additional information was provided.
 
Manufacturer Narrative
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. Evaluation of the submitted images confirmed a twist in the outflow graft which could have contributed to the low flow events that were confirmed in the submitted log files. Evaluation of the submitted images appeared to show a twist in the outflow graft material near the outflow graft attachment. The degree that the graft was twisted and the duration that the twist was present could not be conclusively determined through the evaluation of the images. Although a specific cause for the twist in the sealed outflow graft could not conclusively be determined through this evaluation, it appeared to have contributed to the low flow events that were observed in the submitted log files. The patient remains ongoing on heartmate 3 lvas, serial number (b)(4) and no related complaints have been reported at this time. The heartmate 3 lvas ifu contains information regarding the preparation of the sealed outflow graft. This document instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight. When de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring. Failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding. The ifu also outlines all system controller alarm conditions, including the low flow hazard, as well as the appropriate actions associated with each alarm. A review of the device history records revealed the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
 
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
MDR Report Key7546687
MDR Text Key109412521
Report Number2916596-2018-02197
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 09/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model Number106524
Device Catalogue Number106524
Device Lot Number5834248
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1774-2018

-
-