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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Catalog Number 106524
Device Problems Partial Blockage (1065); Kinked (1339)
Patient Problem Mitral Regurgitation (1964)
Event Date 03/26/2018
Event Type  Injury  
Manufacturer Narrative
The patient age was not provided. (b)(4). Approximate age of device ¿ 5 months. The device was returned for investigation. The evaluation is not yet complete. 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 as a bridge to transplant. It was reported that on (b)(6) 2018, the patient experienced numerous low flow alarm events. The patient reportedly had severe mitral regurgitation, which the healthcare professionals attempted to offload with higher flows. An echocardiogram was completed, which showed normal velocities through the inflow cannula. A ct scan of the chest showed no abnormalities. On (b)(6) 2018, the patient continued to experience low flows and the aortic valve opened with every beat despite higher than expected flows. On (b)(6) 2018, the patient underwent a pump exchange. On explant of the pump and disconnection of the outflow graft bend relief, there was noted distortion of the proximal end of the outflow graft. No further information was provided at the time of this report.
 
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.
 
Manufacturer Narrative
The evaluation of heartmate 3 lvas confirmed several creases in the graft material at the proximal end of the sealed outflow graft. Evaluation of the device's blood-contacting surfaces revealed no evidence of developed depositions or thrombus formations. Visual inspection of the sealed outflow graft revealed creases in the dacron material oriented in a clockwise direction, adjacent to the attachment hardware. Although a specific cause for these creases could not conclusively be determined, past experience with the heartmate product line and similar reported events suggest that the graft may have been twisted during support. Furthermore, although a duration of time for which a twist was present could not be determined through this evaluation, it could have contributed to the low flow alarms that were confirmed through the submitted log files. The pump was cleaned, reassembled, and operated on a mock circulatory loop. The device functioned as intended and in accordance with manufacturing specifications. The heartmate 3 lvas instructions for use (ifu) 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. This document also explains that the low flow hazard alarm will be triggered when pump flow is less than 2. 5 lpm and notes that changes in patient conditions can result in low flow. A review of the device history records, including the sterilization and packaging documentation, found no deviations from manufacturing specifications. The manufacturer is closing the file on this event.
 
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Brand NameHEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
Type of DeviceLEFT VENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6101 stoneridge dr.
pleasanton, CA 94588
7818528390
MDR Report Key7442942
MDR Text Key105905719
Report Number2916596-2018-01400
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number106524
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2017
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: 04/19/2018 Patient Sequence Number: 1
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