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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 Problems Partial Blockage (1065); High Readings (2459)
Patient Problems Hemolysis (1886); Renal Failure (2041); Thrombus (2101)
Event Date 03/28/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Approximate age of device ¿ 1 year. Device evaluation: the explanted pump was returned assembled with the driveline severed approximately 7 inches from the pump housing. The remainder of the driveline was not returned. Ring-like thrombus formations were observed surrounding the inlet bearing cup and bearing ball, partially obstructing the flow of blood. The similarity in structure of these thrombus formations indicate that they likely formed as one thrombus and were pulled apart during disassembly of the pump. The laminated structure of this thrombus and the observed areas of denaturation indicate that it likely formed over an indeterminate duration while the device was supporting the patient. Although a direct cause for the development of the thrombus and a duration for which it was present within the pump could not be conclusively determined, it could have contributed to the reported elevation in ldh. A direct correlation between the device and the reported outflow graft stenosis could not be conclusively determined through this evaluation. The pump bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies related to wear or damage were observed that would have contributed to a functional issue. Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts. 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 that the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017. It was reported that the patient was elevated to status 1a on the transplant list secondary to pump thrombosis. The patient had a previously unreported history of elevated lactate dehydrogenase (ldh) and an lvad outflow graft stenosis per ct scan. The spike in ldh started on (b)(6) 2017. On (b)(6) 2017, the patient¿s ldh peaked at 1783 u/l and normalized to range of 375 u/l on (b)(6) 2017. In may, ldh remained chronically elevated in the 500-900 u/l range and peaked to 1144 u/l on (b)(6) 2017. On an unspecified date, the patient was admitted to the hospital due to an elevated ldh and was treated with a heparin infusion. The patient¿s target inr goal was increased from 2-3 to 3-3. 5. In addition 75 mg tid of diypyridamole was added. Upon admission for transplant on an unspecified date, the patient had low hemoglobin and hematocrit results and ldh was found to be greater than 1700 u/l. The patient received a heart transplant on (b)(6) 2018. The pump was returned for analysis. No additional information was provided.
 
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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 Key7298070
MDR Text Key101001631
Report Number2916596-2018-00701
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Catalogue Number106015
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2016
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: 02/26/2018 Patient Sequence Number: 1
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