MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524INT

Device Problems Mechanical Problem (1384); Pumping Stopped (1503); Malposition of Device (2616); Infusion or Flow Problem (2964); Material Twisted/Bent (2981)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Aortic Dissection (2491); Blood Loss (2597); Vascular Dissection (3160)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was admitted on (b)(6) 2020 due to low flow, low pi, and low power.An echo was performed and showed a normal rv function, no suction of the inflow, sufficient inflow position.Patient felt okay, but general condition was reduced.Hemodynamic needed medical treatment by catecholamines and he was readmitted.A ct-scan was performed to exclude issues with the outflow.The result showed a severe occlusion of the outflow graft below the bend relief.An outflow graft twist was suspected.The clinic did a coronary angiography on (b)(6) 2020 and the video confirmed the twisting in the suspected area.A direct re-exploration was scheduled.The patient went back to the operating room in the afternoon to repair or exchange the outflow graft and trying to install an outflow graft clip.During the sawing of the sternum the driveline was cut accidentally.A driveline power fault and short time later a diveline communication fault occurred.Pump was still running.A decision for a pump exchange was taken.Both cannulas for heart lung machine (hlm) were installed into the left groin and the exchange went straight forward, the twist of the outflow graft was confirmed afterwards.A sudden drop in hemodynamic the pump prior going off from bypass and visually the heart stood still without any activity.Trying to get off from bypass was not possible due to no rv activity and consequently no lvad flow occurred.A root cause was not found directly.A decision for temporary rvad was taken.Heart activity did not return for over 20 minutes.After starting the rvad, lvad flow increased to 4 ¿ 4.5 liters and 5 minutes later heart activity came back.Echo showed a new developed and severe dissection of the descending aorta which resulted in bleeding.The cannulation of the arterial line of the hlm was suspected as root cause.Medical treatment was escalated, and the patient was transferred under low hemodynamic conditions to the icu.Both devices were running with about 2 liters dependent on high volume substitution.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of heartmate 3 lvas, serial number (b)(6) confirmed the report of an outflow graft twist, which would have contributed to the low flow events confirmed through the evaluation of the submitted log files.The submitted controller event log file contained data on (b)(6) 2020 from 9:48:15 to 12:37:07.There were numerous captured events where the calculated flow was below the low flow threshold of 2.5 lpm, resulting in 138 low flow faults and 63 low flow alarms.The pump operated at the set speed for the duration of the log file.The submitted images showed the outflow graft after explant which confirmed a twist to the sealed outflow graft under the bend relief adjacent to the graft attachment.Additionally, the submitted video revealed a suspected outflow graft twist during patient support.(b)(6) was returned assembled with the pump cable severed approximately 9¿ from the pump housing.The distal portion of the pump cable and the modular cable were not returned.The sealed outflow graft was returned to the outlet port.The bend relief was returned unattached.The apical cuff was not returned.Examination of the sealed outflow graft revealed a twist adjacent to the graft hardware traveling length wise on the graft.Based on the tissue accumulation in the space between the graft and bend relief, the twist appeared to have been present for an unknown period of time during patient support.The occlusion caused by the twist would have contributed to the gradual decrease in average flow and subsequent low flow alarms captured in the submitted log files.Upon disassembly of the returned pump, examination of the blood-contacting surfaces revealed no adhered depositions or thrombus formations that would have contributed to a flow or functional issue.Visual inspection of the pump rotor and rotor well did not reveal any obvious surface scratches or defects.The pump was reassembled and operated on a mock circulatory loop and functioned as intended in accordance with manufacturing specification.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump was shipped on 14aug2017.Heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.This ifu contains information regarding the preparation of the sealed outflow graft in section 5 ¿surgical procedures¿.This section instructs the user to 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 ensuring that the line is straight.This section also explains that when de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring until it engages in place.This section warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may lead to serious adverse events such as low left ventricular assist device flow.Section 5 also instructs the user to stretch the graft completely and then measure and cut the sealed outflow graft to the appropriate length under ¿attaching the sealed outflow graft to the aorta.¿ section 1 of the heartmate 3 lvas ifu "introduction" provides an explanation of all pump parameters, including flow.This section explains that pump flow is a calculated value that is estimated based on pump power.Section 4 "system monitor" provides information about the pump flow display and the low flow hazard alarm condition.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm and explains that changes in patient conditions can result in low flow, such as hypertension.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard alarm, as well as the appropriate actions associated with them.Heartmate 3 lvas patient handbook is currently available.Section 5 "alarms and troubleshooting" outlines all system controller alarms, including the low flow hazard alarm, as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Additional information to manufacturer's investigation conclusion: the patient remained ongoing on heartmate 3 lvas, serial number (b)(6) until they passed away.(b)(6) was not returned to abbott for evaluation (refer to manufacturer report number #2916596-2020-05868).The retrieved lvad event log file contained numerous ¿scia¿ and "scib" events, which are the result of controller communication faults.These events appeared to be consistent with the report of the pump cable being damaged during the outflow graft revision.Examination of the sealed outflow graft revealed a counter-clockwise twist adjacent to the graft hardware traveling length wise on the graft.The lvad event log file was retrieved from the returned pump.The log file contained numerous ¿scia¿ and "scib" events, which are the result of controller communication faults.These events appeared to be consistent with the report of the pump cable being damaged during the outflow graft revision.Heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.The hm3 ifu lists bleeding as an adverse event that may be associated with the heartmate 3 left ventricular assist system.The ifu also provides information regarding anticoagulation, including the recommended inr values.Section 5 of this document cautions that sharp bends, twists, or kinks in the driveline may make it more susceptible to wear and fatigue over time.Section 6 of this document cautions the user to avoid pulling on or moving the driveline.This section emphasizes not to twist, kink, or sharply bend the driveline, system controller power cables, or mobile power unit patient cable, which may cause damage to the wires inside, even if the external damage is not visible.Damage to the driveline or cables could cause the pump to stop.If the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten.Section 7 of this ifu also provides instruction regarding the driveline in a sub-section entitled "what not to do: driveline and cables".Section 8 of this ifu provides additional information regarding the driveline via ¿care of the driveline¿.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10861961
• MDR Text Key: 216946359
• Report Number: 2916596-2020-05755
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: 106524INT
• Device Lot Number: 6098682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 02/02/2021; 02/23/2021
• Supplement Dates FDA Received: 02/08/2021; 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q118-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention