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

Model Number 106015

Device Problem Partial Blockage (1065)

Patient Problem Thrombus (2101)

Event Date 02/09/2018

Event Type  Death  

Manufacturer Narrative

Approximate age of device- 10 days.Manufacturer's investigation conclusion: thrombus was confirmed through the evaluation of heartmate ii lvas.Heartmate ii lvas was returned assembled with the driveline (dl) cut approximately 8.5¿ from the pump housing and the distal portion of the dl was not returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned attached to the pump¿s inlet port.The sealed outflow conduit (outflow graft, bend relief and outlet elbow) was returned attached to the pump¿s outlet port.The sealed outflow graft bend relief collar was sutured around the outflow graft nut.Upon disassembly of heartmate ii lvas, the outlet elbow revealed a thrombus formation.The thrombus appeared to obstruct majority of the blood flow path.The thrombus formation was adhered to the textured blood-contacting surface of the outlet elbow and its structure suggests that it formed within the outlet elbow over an undetermined amount of time while the pump was supporting the patient.The evaluation could not determine a specific cause for the development of the observed thrombus formation within the outlet elbow.Examination of the remaining blood-contacting surfaces of the returned device revealed no additional depositions or thrombus formations that would have contributed to a functional or flow issue.A correlation between the thrombus formation and the patient¿s respiratory failure could not conclusively be established through this evaluation.Additionally, a specific cause of the reported sepsis and infection could not conclusively be determined through this evaluation.Upon removal of the observed depositions, the device was cleaned.The pump's bearings, rotor, and blood-contacting surfaces were then examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline revealed no 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.

Event Description

The patient was implanted with left ventricular assist device (lvad) on (b)(6) 2018.It was reported that the patient expired on (b)(6) 2018 due to respiratory arrest and sepsis.Sepsis was not related to a driveline or a pump pocket infection.There were no device malfunctions reported for this event.During the manufacturer's investigation, pump thrombus was found and may have contributed to patient's death.

• 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
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7836239
• MDR Text Key: 118861835
• Report Number: 2916596-2018-03503
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5922518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 42 YR
• Patient Weight: 119