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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
Model Number 106015
Device Problem Partial Blockage (1065)
Patient Problems Hemolysis (1886); Thrombus (2101)
Event Date 02/15/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Approximate age of device ¿ 5 months. The explanted pump is expected to be returned for evaluation. It has not yet been received. 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 patient presented with elevated lactate dehydrogenase (ldh) and was admitted into the hospital on (b)(6)2018, and was given tissue plasminogen activator without a resolution of the hemolysis. The patient was administered iv heparin; however, their ldh continued to rise over 1400 u/l. The patient was asymptotic. A ramp echocardiogram showed the pump was not functioning properly and the left ventricle was decompressing. On (b)(6) 2018, the patient¿s ldh was over 1800 u/l, and subsequently their pump was exchanged. Only the pump body was exchanged. The explanted pump was examined at the hospital and a thrombus was visualized at the inflow conduit and outflow graft. The patient¿s pump parameters were observed to be normal after the original pump was exchanged.
 
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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
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6101 stoneridge dr.
pleasanton, CA 94588
7818528390
MDR Report Key7445972
MDR Text Key106009724
Report Number2916596-2018-01412
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
Reporter Occupation
Type of Report Initial
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Model Number106015
Device Catalogue Number106015
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/20/2018 Patient Sequence Number: 1
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