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Model Number 106015
Device Problem Partial Blockage (1065)
Patient Problems Dyspnea (1816); Thrombus (2101); Palpitations (2467)
Event Date 11/03/2017
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr. Report # 2916596-2017-02979. This report is being submitted as additional information. Approximate age of device-3 years and 11 months. Manufacturer's investigation conclusion: the reported event of thrombus in the outflow graft could not be confirmed through the evaluation of heartmate ii lvas. However, the investigation did confirm the presence of a sealed outflow graft kink. No log files were submitted; therefore, the low flow events could not be confirmed during this investigation. The device was returned assembled with the driveline (dl) severed approximately 2. 5¿ from the pump housing; the severed portion of the dl was not returned. The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was not returned. The sealed outflow conduit (sealed outflow graft, sealed outflow graft bend relief, and outlet elbow) were returned attached to the pump¿s outlet port. The sealed outflow graft bend relief collar was returned sutured around the outflow graft and bend relief hardware. Visual inspection of the sealed outflow graft upon disassembly of the device revealed a lengthwise kink in the proximal half of the graft material. Normal tissue ingrowth between the graft and the bend relief was observed. This ingrowth was smooth and formed around the graft kink, suggesting that the graft had been kinked for an undetermined period of time while the device was supporting the patient. The lumen of the outflow graft revealed no evidence of any developed or adhered depositions or thrombus formations. Although a specific cause for the observed kink in the outflow graft could not be conclusively determined through this evaluation, it could have potentially contributed to the reported low flow events. Evaluation of the sealed inflow conduit revealed no evidence of developed depositions or thrombus formations. Visual inspection of the blood-contacting surfaces within the pump revealed no evidence of depositions or thrombus formations. Examination of the pump bearings, rotor, and blood-contacting surfaces did not reveal any anomalies. 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 that met manufacturing specification and the device functioned as intended. The heartmate ii lvas ifu provides an explanation of all pump parameters, including pump flow and explains that pump flow is estimated from pump power and addresses assessing pump flow. The ifu also provides instructions regarding the preparation, installation, and orientation of the sealed outflow graft. The ifu specifically states: "the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component or body structure" and "verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief. The line should be straight. " the ifu outlines all system controller alarms, including the low flow hazard alarm, as well as how to respond to each alarm condition. 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
It was reported that the patient was admitted on (b)(6) 2017 due to low flow events, symptoms of palpitations, some shortness of breath, and occasional dizziness. The echocardiogram showed reduced right ventricular and left ventricular systolic function. It was reported during the right heart catheterization, the pump speed was increased with no improvement in hemodynamics. It was reported that there was inadequate left ventricular unloading and cardiac output despite left ventricular assist device. A milrinone infusion was started and a cardiothoracic angiogram (cta) was performed. The cta showed nonocclusive thrombus in the outflow graft causing severe narrowing. The ldh is unchanged from baseline of 250-330 u/l. The inr has not been subtherapeutic. The patient was taken to the operating room for pump exchange on (b)(6) 2017. No further information was provided.
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Manufacturer (Section D)
6035 stoneridge drive
pleasanton CA 95488
Manufacturer (Section G)
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
MDR Report Key8040686
MDR Text Key126218913
Report Number2916596-2018-04883
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2016
Device Model Number106015
Device Catalogue Number106015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/13/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/30/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/05/2018 Patient Sequence Number: 1