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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 Problem Thrombus (2101)
Event Date 10/26/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Approximate age of device - 3 years, 8 months. A correlation between the device and the reported aortic dissection and patient death could not be conclusively determined. However, evaluation of the returned pump confirmed the presence of thrombus inside the pump. The pump was returned assembled. The percutaneous lead (driveline) was severed approximately 2 inches from the pump housing. The severed portion of the driveline was not returned. All parts of the sealed inflow conduit were returned. The sealed outflow graft, bend relief, and bend relief collar were not returned. The outlet elbow was returned. The inlet stator revealed red, grainy depositions, which appeared consistent with denatured blood. Furthermore, the rotor bearing ball revealed a dark red, tissue-like deposition. The thrombus had areas that were denatured and had a ring-like structure with laminate layering, which are indications that it likely developed over an undetermined period of time around the bearings while the pump was in operation. The deposition was of moderate size and would have impeded flow if it was present during pump operation. A specific cause for the deposition and a time frame for which it was present in the pump could not be determined. No other depositions were identified. The pump¿s bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies were observed. Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts. The pump was cleaned, reassembled, and functionally tested under normal operating conditions using a mock circulatory loop. The data retrieved from that testing revealed normal pump power consumption and pressure values, comparable to what was recorded during the manufacturing process; the device functioned as intended. A review of the device history records revealed 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) 2014. It was reported that the patient expired on (b)(6) 2017. Information provided referenced the cause of expiration as aortic dissection secondary to calcification. The lvad clinician believed that there had been no lvad pump issues and the pump was working properly. The patient had a history of discitis and was receiving daily abx in the hospital¿s short stay unit. The patient also had a known mycotic splenic artery aneurysm that had recently received over 20 coils to control the bleeding. On examination, this was still intact, though enlarged upon the patient¿s expiration, and was not the cause of death. However, the investigation of the related lvad ((b)(4)) identified a deposition (thrombus formation) found during the analysis of the returned explanted pump.
 
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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 Key7289882
MDR Text Key101010606
Report Number2916596-2018-00658
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 Other Health Care Professional
Type of Report Initial
Report Date 02/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number106015
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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