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

Model Number 106015

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problems Abdominal Pain (1685); Hemolysis (1886); Thrombus (2101)

Event Date 05/06/2018

Event Type  Injury  

Manufacturer Narrative

Approximate age of device - 11 months.The explanted device is expected to be returned for analysis.It has not yet been received.No additional information was provided.A supplemental report will be submitted when the device analysis is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the patient was admitted to the intensive care unit with acute abdominal pain.The patient's lactate dehydrogenase (ldh) level was in the 400 u/l range.Heparin and integrilin were administered, and the ldh came down to the 200 u/l range.The echocardiogram revealed an enlarged left ventricle, the aortic valve was not opening, and the septum had shifted over to the right ventricle.On (b)(6) 2018 the lvad was explanted and the patient was placed on an extracorporeal circulatory support device.On (b)(6) 2018, the patient underwent a second lvad implant.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported event could not conclusively be established through the evaluation.No device-related issues were identified through the evaluation of the pump.Evaluation of the submitted log file confirmed the reported power and flow elevations; however, a specific cause for these findings could not conclusively be determined, and the pump appeared to function as intended.The pump was returned assembled with the percutaneous lead (driveline) cut approximately 2¿ from the pump housing and the distal portion of the driveline was not returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned detached from the pump¿s inlet port.The sealed outflow graft, sealed outflow graft bend relief, and sealed outflow graft bend relief collar were returned detached from the device.The sealed outflow graft bend relief collar was sutured in place around the outflow graft nut.The outlet elbow was returned attached to the pump's outlet port.Upon disassembly of the device, the interior of the inflow knitted graft revealed a white tissue-like biological lining that pulled out upon disassembly.The tissue lining appeared consistent with poor surface washing in this location due to a low flow condition, however, a specific cause for the potential low flow state could not be conclusively determined.The lining did not appear to have obstructed blood flow through the device.The disassembled pump¿s bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline did not reveal any discontinuities or shorts.The pump was 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 and 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.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7558394
• MDR Text Key: 109749328
• Report Number: 2916596-2018-02087
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6004977
• Other Device ID Number: 00813024011224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 109