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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA Back to Search Results
Model Number 106015
Device Problem Partial Blockage (1065)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2018
Event Type  malfunction  
Manufacturer Narrative
The referenced pump exchange performed on (b)(6) 2018 is covered under medwatch mfr report # 2916596-2018-02499. Approximate age of device- 4 years and 8 months. Manufacturer's investigation conclusion: the explanted pump was returned for evaluation. The evaluation of the pump confirmed driveline damage that could have resulted in pump stoppage events which was reported under medwatch mfr report # 2916596-2018-02499. This medwatch report covers the incidental investigation findings of thrombus. The pump was returned assembled with the driveline severed approximately 7. 5 inches from the pump housing and the distal portion was returned measuring approximately 31. 5 inches. The sealed inflow conduit and sealed outflow graft conduit were not returned. Tissue-like depositions were identified on the proximal side of the outlet stator. The tissue lacked laminated layering which indicated that it did not initially form in the outlet stator. There was no evidence of lamination or denaturing and there were no contact marks on the rotor to indicate that it was present in the pump while it was operating. A specific cause for the depositions and a duration of which it was present in the pump could not be conclusively determined. Thrombus is 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) 2013. On (b)(6) 2018, the patient underwent a pump exchange due to pump stoppages suspected to have been caused by a short to shield issue. Investigation of the related lvad identified tissue-like depositions on the proximal side of the outlet stator.
 
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Brand NameHEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
Type of DeviceLEFT VENTRICULAR ASSIST SYSTEM
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key7920897
MDR Text Key122307390
Report Number2916596-2018-04322
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011224
UDI-Public00813024011224
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Model Number106015
Device Catalogue Number106015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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