MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Fatigue (1849); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is completed.

Event Description

It was reported that the patient presented with elevated flows and powers on (b)(6) 2021.The patient had mild symptoms: fatigued and slight increase in shortness of breath with activity.Their urine output was a normal pale clear yellow but ldh (lactate dehydrogenase) was elevated.The patient was on coumadin and aspirin, and a heparin drip was started when admitted to hospital for suspected pump thrombosis.Log file analysis captured an increase in power and a decrease in average pulsatility index (pi) over time as well as a few low battery advisory alarms (due to normal battery depletion).The patient underwent a hmii (heartmate ii) to hm3 (heartmate 3) pump exchange on (b)(6) 2021 for suspected pump thrombosis.The patient's ldh continued to trend downwards post pump exchange.There were no unusual events recorded in the log file event history.

Manufacturer Narrative

Manufacturer's investigation conclusion: thrombus was confirmed through the evaluation of heartmate ii lvas, serial number (b)(6).A direct correlation to the heartmate ii lvas, serial number (b)(6), and the reported events could not conclusively be determined through this evaluation.The submitted log file contained data from 20:02:13 on (b)(6) 2021 through 13:57:48 on (b)(6) 2021, per the timestamps.Throughout the captured data, elevations in pump power as high as 18.2 w were captured.Corresponding elevations in pump flow, as high as 12.0 lpm, were also captured.The pump operated above the low speed limit for the duration of the log file.A specific cause for these findings could not be determined through this evaluation.(b)(6) was returned assembled with the driveline (dl) cut approximately 2.5¿¿ from the pump housing and the distal end of the driveline was not returned.The sealed inflow conduit and sealed outflow graft were not returned.The proximal and distal-sides of the pump stators showed no evidence of deposition or thrombus.The outlet elbow was returned attached to the outlet port.Upon disassembly of (b)(6) , visual inspection of the rotor bearing ball revealed a small, denatured thrombus.The thrombus showed evidence of laminated layering indicating that it formed in this location over an undetermined amount of time.The deposition found in the pump could have potentially contributed to the reported hemolysis.The deposition could have also created additional resistance on the spinning rotor, potentially contributing to the reported elevations in pump power.Upon removal of the observed deposition, the device was cleaned.The pump¿s bearings, rotor and blood-contacting surfaces were 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 the testing revealed normal pump power consumption and pressure values, comparable to what was recorded during the manufacturing process and the device functioned as intended.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 27dec2017.The heartmate ii lvas ifu and the heartmate ii patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists hemolysis and device thrombosis as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, also lists thromboembolism as a potential late postimplant complication.Section 1 and section 6 of the ifu also outline indications of pump thrombosis and how to respond to such events.Section 6, under ¿anticoagulation¿, provides information regarding the recommended anticoagulation therapy and inr range, as well as suggested anticoagulation modifications.Section 1 also addresses all pump parameters including pump power.This section explains that pump power is a direct measurement of motor voltage and current; therefore, changes in pump speed, flow, or physiological demand can affect pump power.This section also notes that any increase in power not related to increased flow causes erroneously high flow readings.Additionally, section 6, under ¿pump performance monitoring¿, explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• 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 ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12748580
• MDR Text Key: 280008563
• Report Number: 2916596-2021-05909
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6257935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 80 KG