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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 106015
Device Problem Partial Blockage (1065)
Patient Problems Death (1802); Hemolysis (1886); Thrombus (2101)
Event Date 12/11/2017
Event Type  Death  
Manufacturer Narrative
A direct correlation between the left ventricular assist system (lvas) and the reported event could not conclusively be established through this evaluation. No log files were submitted for evaluation; the report of low flow alarms was not confirmed. Thrombus and hemolysis are listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system. A review of the device history records revealed no deviations from manufacturing or quality assurance specifications. No further information was provided. The manufacturer is closing the file on this event.
 
Manufacturer Narrative
(b)(4). Approximate age of device - 2 years and a month. (b)(4). The pump was not explanted and therefore will not be returned for evaluation. 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) 2015. The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2015. It was reported that the patient had fatigue, weakness, shortness of breath and the device had low flow alarms. The patient called 911 and was emergently transported to the hospital. On admission, the inr was 3. 9, lactate dehydrogenase was 415 u/l and 469 u/l, plasma free hemoglobin of 20 mg/dl and 40 mg/dl. The patient was started on dobutamine in emergency room. Ramp echocardiogram revealed little change in the left ventricular size, and the aortic valve remain open despite speed changes. A cardiac ct angiogram showed an adherent thrombus in the outflow graft. The patient was switched from dobutamine to milrinone. Cardiothoracic surgery was consulted; however the patient was deemed not a surgical candidate for pump exchange or heart transplant. Hospice consult was offered but the patient and family refused. The patient was given integrilin and plavix initially with no effect. Tissue plasminogen activator bolus and infusion was also administered with no effect. The patient had to be intubated due to probable pulmonary edema. The patient expired on (b)(6) 2017 secondary to ventricular fibrillation and ventricular tachycardia arrest.
 
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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 Key7249732
MDR Text Key107793399
Report Number2916596-2018-00507
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2017
Device Catalogue Number106015
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2015
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: 02/07/2018 Patient Sequence Number: 1
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