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

Model Number 106524INT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908); Ischemia (1942); Right Ventricular Dysfunction (2054)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

No further information was provided.The patient remains ongoing on the device.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient presented with weakness on the right side on the 5th day after lvad implant.A brain ct showed slight ischemia in the left hemisphere.The patient is taking enalapril for hypertension post stroke.The healthcare provider noted that the patient's gradually worsening tricuspid regurgitation, now severe, dilated right ventricle, and the slit-like left ventricle with progressive shift to left despite volume correction may suggest that right ventricle dysfunction is predominating, and that lack of urine for several hours earlier that day may be an indication of early clinical signs of failure.Pump speed was reduced.No further information was provided.

Manufacturer Narrative

Section b5: additional information manufacturer's investigation conclusion: the report of low flows was confirmed through the analysis of the submitted log files.Although the cause of the reported low flow alarms cannot be conclusively determined through this evaluation, the center reported that the low flow events were caused by infrequent arrhythmias.Adjustments to the patient¿s medications were made and the patient then had a significant improvement in pump flow.A direct relationship between the device and the reported events, including the arrhythmias, could not be conclusively determined.The account reported that the patient was doing well but had several low flow alarms over the past few days.The system controller event log file captured 3 low flow hazard alarms occurring on (b)(6)2020 at 04:47:11, on (b)(6)2020 at 15:42:10, and on (b)(6)2020 at 05:03:46.These low flow hazard alarms occurred when the estimated flow dropped below the 2.5 lpm threshold.There were also several controller fault flags for low flow captured throughout the log file; however, these flags were not active long enough to trigger alarms.Of note, these low flow hazard alarms and low flow controller fault flags appeared to be associated with elevations in pi.No additional atypical alarms or trends in pump parameters were captured.The pump appeared to function as intended.It was later reported that on (b)(6)2020 at 04:47 the patient was in bed.Their map was stable, but their pasp was lower.An echocardiogram was done performed on (b)(6)2020 showed reduced lv size.The patient received iv lasix with albumin daily the week before.Oral lasix was stopped on (b)(6)2020.On (b)(6)2020 at 15:42, the patient was undergoing physiotherapy and sat up.This low flow alarm was associated with dizziness.Once in bed, the patient¿s symptoms resolved, and flows returned to baseline.Hydralazine was stopped and the patient continued on 40 mg of isobide and 5 mg of enalapril bid (for previous hypertension post stroke).On (b)(6)2020 at 05:02, the patient was in bed with stable map.During morning rounds, isobide was reduced to 10 mg bid.Lasix continued to be withheld.A bed-side internal jugular ultrasound showed collapsible internal jugular vein.The overall impression was that the low flow events were related to volume contraction.Therefore, the patient¿s volume was being corrected gradually.The patient¿s sodium level improved and, as of (b)(6)2020 , no further alarms were noted.It was later reported that the impression from the latest imaging and echocardiogram findings was that the patient¿s volume was generally okay.The patient had been running a slightly positive balance daily.Despite good urine output the few days prior, the patient had not passed any urine since the morning of (b)(6)2020.A dose of 20 mg of iv lasix was given at noon and the patient responded well right away.Specific views of the patient¿s inferior vena cava (ivc) were obtained.These images showed gradually worsening tricuspid insufficiency (ti), which was not clearly severe, the patient¿s dilated right ventricle (rv), which was thought to be a little more dilated than before, and the slit-like left ventricle (lv) with progressive shift to the left despite volume correction may have suggested that rv dysfunction was predominating, and that the lack of urine for several hours earlier in the day on(b)(6)2020 may have been an indication of early clinical signs of failure.After discussing with the team members, the patient¿s pump speed was reduced by 100 rpm on (b)(6)2020 and their hematocrit was corrected from 43 to 35.As a result, the patient¿s flows were 3.9 lpm as opposed to 3.5 lpm.The patient¿s dose of enalapril was lowered to 2.5 mg bid to help with the patient¿s dizziness so that the patient could partake in their rehab.A bed side swallowing assessment showed that the patient was at a high risk of aspiration for liquids, but a pureed diet could be given.It was later reported that the patient presented with a weakness on their right side post lvad implant on postoperative day (pod) 5.A ct scan of the brain confirmed a slight ischemic in the left hemisphere.No additional information was provided by the treating health care provider concerning the patient¿s treatment plan.However, as of(b)(6)2020 , the patient was doing better and was discharged from the icu.The patient¿s rv dysfunction/failure was not device related.The patient was known to have an acute myocardial infarction (ami) due to their right coronary artery occlusion (less than 40%), which was not suggested for stenting, or even coronary artery bypass grafting (cabg), and was left for medical treatment only which led to the moderate rv dysfunction post lvad implant.It was later reported that the low flow alarms and pi events were caused by infrequent arrhythmias.It was reported that the arrhythmias were not device related.The patient was hemodynamically stable and was treated with a low dosage of milrinone for 24 hours and amiodarone for 48 hours.The patient¿s ace inhibitor was reinitiated, and their beta blocker dosage was increased.The patient had a significant improvement in pump flow after this treatment.As of (b)(6)2020 , the patient was stable and under final preparations for hospital discharge.The patient remains ongoing on vad support.Cardiac arrhythmia, right heart failure, and stroke are listed in the hm3 lvas ifu as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Pulmonary hypertension is listed in the hm3 lvas ifu as a potential risk and adverse event.The patient care and management section of the hm3 lvas ifu contains subsections entitled ¿right heart failure¿ and ¿blood pressure management.¿ the surgical procedures section of the hm3 lvas ifu states that moderate to severe aortic insufficiency must be correct at time of device implant.The introduction of the hm3 lvas ifu explains the pump parameters, including flow.Per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.The hazard alarms sub-section of the hm3 lvas ifu notes that ¿changes in patient conditions can result in low flow, such as hypertension.¿ the alarms and troubleshooting section explains all system alarms, including low flow alarms, and the recommended actions associated with them.No further information was provided.The manufacturer is closing the file on this event.

Event Description

As of (b)(6)2020 , the patient was doing better and had been discharged from the icu.The right heart failure was not device related.The patient had an acute myocardial infarction due to occlusion of the right coronary artery (<40%).No surgical treatment was recommended and the patient received only medical treatment for this, which led to moderate rv dysfunction.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9920416
• MDR Text Key: 186283830
• Report Number: 2916596-2020-01859
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2020

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: 09/11/2021
• Device Model Number: 106524INT
• Device Lot Number: 6763400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 58