MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE; LEFT VENTRICULAR ASSIST SYSTEM

Model Number 106524

Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)

Patient Problem Dizziness (2194)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

The patient's weight was not provided.The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing (b)(6) trial.(b)(4).Approximate age of device - 1 year and 7 months, 1 day.The pump remains in use supporting the patient.No further information was received.A supplemental report will be submitted when the manufacturer's investigation is completed.Abbott has decided to initiate a voluntary field action for all lot numbers of heartmate iii distributed since september 2014.Internal investigation performed by abbott has determined there is a potential for an outflow graft occlusion due to twisting.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification determined that bend relief rotation is inconsistently translated to the outflow graft hardware.A risk/benefit analysis was performed and it was determined that despite the potential for an outflow graft occlusion due to twisting, the associated residual risks are low and are considered acceptable.As a corrective action, consignees have been notified of the potential occlusion due to twisting.Additionally, abbott will continue to trend complaints related to this event based on original event description and/or results of product evaluation.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016.It was reported that the patient came into the clinic because the system controller was alarming for sustained/persistent low flow that did not respond to traditional interventions.The patient's aortic valve (av) was unable to close at a higher tested speed.Computed tomography angiography (cta) confirmed that there was an outflow graft (ofg) twist, and the inflow cannula appeared to be positioned incorrectly.The surgeon planned to take the patient to the operating room (or) monday, (b)(6) 2018, to untwist the ofg and open up the pericardium to reposition the pump.

Manufacturer Narrative

Manufacturer's investigation conclusion: a full evaluation of the device could not be conducted as the device remains implanted supporting the patient.Evaluation of the submitted ct images and video confirmed a twist in the outflow graft which could have contributed to the low flow events that were confirmed in the submitted log files.Evaluation of the submitted images and video appeared to show a twist in the outflow graft material near the outflow graft attachment.The degree that the graft was twisted and the duration that the twist was present could not be conclusively determined through the evaluation of the images/video.The heartmate 3 lvas ifu contains information regarding the preparation of the sealed outflow graft.This document 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 and ensuring that the line is straight.When de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring.Failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding.This ifu also warns that care should be taken to avoid orienting the inlet towards the interventricular septum as pump function will be compromised in the presence of inlet obstruction.In addition, this document outlines all pump parameters and provides information regarding the assessment of pump flow.The ifu also outlines all system controller alarm conditions, including the low flow hazard, as well as the appropriate actions associated with each alarm.Abbott decided to initiate a voluntary field action for all lot numbers of heartmate iii distributed since september 2014.Internal investigation performed by abbott has determined there is a potential for an outflow graft occlusion due to twisting.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification determined that bend relief rotation is inconsistently translated to the outflow graft hardware.A risk/benefit analysis was performed and it was determined that despite the potential for an outflow graft occlusion due to twisting, the associated residual risks are low and are considered acceptable.As a corrective action, consignees have been notified of the potential occlusion due to twisting.Additionally, abbott will continue to trend complaints related to this event based on original event description and/or results of product evaluation.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.

Manufacturer Narrative

This report is being submitted late as a part of the correction required for a capa investigating repeated late submissions of clinical data to the product performance group by a single clinical safety employee.Abbott notified fda of the pending late reports related to this issue.The late reports related to this capa are expected to be submitted to fda by may 31, 2019.Evaluation of the submitted ct images and video confirmed a twist in the outflow graft which could have contributed to the low flow events that were confirmed in the submitted log files.A direct correlation between heartmate 3 lvas, serial number (b)(4) and the reported inflow cannula malposition, atrial thrombus, and arrhythmia could not be conclusively established through this evaluation.Evaluation of the submitted images and video appeared to show a twist in the outflow graft material near the outflow graft attachment.The degree that the graft was twisted and the duration that the twist was present could not be conclusively determined through the evaluation of the images/video.Although a specific cause for the twist in the sealed outflow graft could not conclusively be determined through this evaluation, it appeared to have contributed to the low flow events on (b)(6) 2018 that were observed in the submitted log files.The patient remains ongoing on heartmate 3 lvas, serial number (b)(4) and no additional complaints have been reported at this time.The heartmate 3 lvas ifu lists cardiac arrhythmia and peripheral thromboembolic events as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.The ifu lists thromboembolism as a potential late postimplant complication and provides information regarding anticoagulation, including the recommended inr values.This document also contains information regarding the preparation of the sealed outflow graft.This document 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 and ensuring that the line is straight.When de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring.Failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding.This ifu also warns that care should be taken to avoid orienting the inlet towards the interventricular septum as pump function will be compromised in the presence of inlet obstruction.In addition, this document outlines all pump parameters and provides information regarding the assessment of pump flow.The ifu also outlines all system controller alarm conditions, including the low flow hazard, as well as the appropriate actions associated with each alarm.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The account communicated that the patient went to the clinic for sustained/persistent low flow alarms that were not responsive to traditional interventions.During the sustained low flow alarms the patient reported becoming dizzy.Blood pressure was 70-80 throughout the exam and no other symptoms were reported (no dark urine or shortness of breath).A ramp echo was performed and no obvious obstruction was observed; however, the av was unable to be closed at the higher test speed (6300 rpm).The pump speed was reportedly changed from 5300 rpm to 5900 rpm to achieve higher calculated flow.A ct scan was performed which reportedly confirmed an outflow graft twist and inflow cannula malposition.The patient was to undergo surgery to have the outflow graft untwisted and the pericardium opened for pump repositioning.It should be noted that the report of an inflow conduit malposition could not be confirmed through this evaluation.It was reported that the patient, with a history of atrial fibrillation and flutter, at 72 hours post-op after outflow graft revision surgery had rapid atrial fibrillation with rapid ventricular rate (rvr) to 180 per minute.The patient was dosed with a bolus of intravenous heparin and sent for a transesophageal echocardiography (tee) with plans to cardiovert pre-procedure.Tee revealed the presence of left atrial appendage thrombus.Cardioversion was aborted.Coumadin was to be restarted and the patient was to continue with intravenous heparin.Sotalol was stopped and the rate was controlled with betablockers and anticoagulation.It was reported that the adverse event was not related to the lvas.The cardiovert was cancelled as the patient went into normal sinus rhythm on own and stayed there.The patient was discharged home on (b)(6) 2018.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7661834
• MDR Text Key: 113156740
• Report Number: 2916596-2018-02573
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 106524
• Device Catalogue Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1774-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 94