MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106015

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi) # (device identifier): (b)(4).Approximate age of device ¿ 8 months.Device evaluation: a direct correlation between heartmate ii lvas, serial number (b)(4), and the report of suspected thrombosis could not be conclusively established through this evaluation.In addition, although the evaluation of the submitted system controller log files confirmed the report of low flow alarms, a specific cause for the events could not be conclusively determined.The submitted system controller log file contained data from 09:02:20 am through 01:53:22 pm on (b)(6) 2018.A persistent low flow hazard alarm was observed, associated with the estimated flow being 2.4 lpm (below the low flow threshold of 2.5 lpm) throughout the duration of the data.The pump was returned assembled with the percutaneous lead (driveline) severed approximately 12 inches from the pump housing.The remainder of the driveline was returned in a segment measuring approximately 26.5 inches.The inflow conduit and the outflow graft were not returned.The outlet elbow was returned attached to the pump¿s outlet port.Upon disassembly of the returned device, visual inspection of the smooth and textured blood-contacting surfaces revealed no evidence of developed depositions or thrombus formations that would have contributed to the reported flow issues or elevation in lactate dehydrogenase (ldh).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.Functional testing of the pump under normal operating conditions revealed normal pump power consumption and pressure values comparable to the data recorded during the manufacturing process.The pump operated as intended.Device thrombosis and hemolysis are listed in the instructions for use as potential adverse events that may be associated with 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 lvad system produced low flow alarms for 2 days.The patient had good urinary output, was pulsatile, had adequate pressures, and mean arterial pressures (maps) were 60-90.There were no signs of heart failure symptoms.It was reported that the patient received plasmapheresis weekly due to myasthenia gravis.Echocardiogram (echo) showed the aortic valve opening every 1-3 beats and the patient¿s left ventricle was not distended.Ejection fraction (ef) was 25%.Echo did not indicate anything impeding the inflow cannula.Ramp study showed left ventricle decompression with increased pump speed.X-ray showed good pump placement.Ct scan with contrast found outflow graft within normal limits (wnl).The patient¿s lactate dehydrogenase (ldh) began to become elevated from 400 u/l to 600 u/l.The patient was asymptomatic and kidney function had not changed.Thrombus was reportedly suspected.The low flow alarms were persistent and continued until pump exchange on (b)(6) 2018.The exchange was performed by subcostal approach and only the pump was replaced.It was reported that an outflow graft clot was found in the pump and a big clot was observed in the outflow graft.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT 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 Key: 7643137
• MDR Text Key: 112506858
• Report Number: 2916596-2018-01774
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 126