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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE

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THORATEC CORPORATION HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Catalog Number 103695
Device Problems Partial Blockage (1065); Pumping Stopped (1503)
Patient Problem Thrombus (2101)
Event Date 03/10/2018
Event Type  Injury  
Manufacturer Narrative
The referenced percutaneous lead replacement was reported under medwatch mfr report #2916596-2018-01208. Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation. Approximate age of device ¿ 7 years and 1 month. 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) 2011. It was reported that post distal end percutaneous lead (driveline) replacement the pump was unable to restart upon insertion of the driveline into the system controller. The pump had been off for approximately 12 hours prior to driveline replacement. A system controller exchange was attempted with same results. The lvad clinician and physician decided to keep the lvad off due to suspected thrombus inhibiting the rotor.
 
Manufacturer Narrative
A direct correlation between the device and the reported event of thrombus could not be conclusively determined. Thrombosis is listed in the instructions for use as a potential adverse event that may be associated with use of the heartmate ii left ventricular assist system. A review of the device history records revealed that the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
It was reported that the healthcare professionals did not suspect thrombus but were concerned that due to the pump being off for an extended period, the resulting stagnant blood could predispose the patient to thrombus. The patient did not have any clinical signs or symptoms of thrombus. The pump was not explanted. The patient was being supported on intravenous (iv) inotropes.
 
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Brand NameHEARTMATE II LVAS
Type of DeviceLEFT VENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
MDR Report Key7396831
MDR Text Key104359086
Report Number2916596-2018-01209
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2013
Device Catalogue Number103695
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/04/2018 Patient Sequence Number: 1
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