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

Model Number 106524US

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Ischemia (1942); Pneumonia (2011); Fungal Infection (2419); Hematuria (2558); Pericardial Effusion (3271); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Unspecified Kidney or Urinary Problem (4503)

Event Date 11/25/2021

Event Type  Death  

Event Description

It was reported that the patient became acutely hypotensive with worsening acidosis and anemia and they returned to the operating room (or) on (b)(6) 2021 for exploration.More than 1 hemothorax and a pericardial effusion were evacuated, however there was a failed chest closure due to obstruction of the outflow graft.While in the or the surgeon also resected the 175cm small bowel that had become ischemic due to emboli.The bowel was left in discontinuity and the abdomen was left open.The patient returned to the or on (b)(6) 2021 for revision of inflow and outflow graft and the chest was closed.The surgeon resected an additional 75cm of small bowel, including the terminal ileum and the right colon.The patient underwent tracheostomy (6.0 flex shiley) placement and bronchoscopy on (b)(6) 2021.The patient remained intermittently febrile, and later developed fungemia (candida) which was treated with fluconazole.Repeat blood cultures in the successive days came back positive for candida albicans so fluconazole was transitioned to micafungin.Additionally, tracheal aspirate noted to be growing klebsiella and enterobacter pneumonia that was treated with meropenem based on sensitivities.The patient's dopamine infusion was transitioned to epinephrine on 07dec2021 for ongoing inotropic and hemodynamic support.On 10dec2021 a right heart catheterization was done.The patient's fick was normal and did not appear grossly fluid volume overload (fvo).They developed hematuria and initially remained on heparin infusion due to need for systemic anticoagulation status post left ventricular assist device (lvad), but this was held starting 12dec2021 due to the hematuria.Heparin was resumed on 15dec2021 tolerating a goal of partial thromboplastin time (ptt) of 40-60 with no increase in hematuria or other bleeding.The patient experienced progressively worsening acute kidney injury (aki) and metabolic acidosis/fvo.Continuous renal replacement therapy (crrt) was started on 14dec2021.Blood cultures on 14dec2021 were negative, and micafungin was to be continued until 27dec2021 to be transitioned to lifelong diflucan.An ultrasound of the abdomen on 17dec2021 showed no acute process, but an ultrasound doppler of the upper extremities bilaterally found chronic occlusion thrombus in the right cephalic vein, complete right internal jugular (ij) occlusion with thrombus that extended to the proximal subclavian.There were several nonocclusive thrombi in the left ij.At this time it was noted that the patient remained do-not-resuscitate (dnr).After recent positive blood cultures with candida and small possibility of clearing their infection, palliative care was consulted on 18dec2021.Sputum culture continued to grow klebsiella despite meropenem therapy.On 21dec2021 the patient's family decided not to escalate care, including no additional infusions and not restarting crrt once the circuit expired.On 22dec2021 epinephrine infusion and crrt were discontinued when the circuit expired.Sedation was increased and the vad was disconnected from power and turned off, along with the ventilator.The patient subsequently passed away peacefully with nursing staff and family at their bedside.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported events could not be conclusively established through this evaluation.Furthermore, the report of obstruction of the outflow graft could not be confirmed.In reference to power, the ifu states that pump power is a direct measurement of pump motor voltage and current.This document also states that changes in pump speed, flow, or physiological demand can affect pump power.The ifu also explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling and outlines all pump parameters.Per design, when the estimated flow value is calculated at less than 2.5 liters per minute (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 will become active.The heartmate 3 patient handbook states that in the event of a low flow hazard alarm, the user is advised to call the hospital contact immediately for diagnosis and instructions.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1, ¿introduction,¿ lists thromboembolism, infection, bleeding, renal dysfunction, and death as adverse events that may be associated with the use of the heartmate 3 lvas.This section addresses all pump parameters including pump power, speed, flow, and pulsatility index (pi).In reference to power, this section states that pump power is a direct measurement of pump motor voltage and current.This section further states that changes in pump speed, flow, or physiological demand can affect pump power.Section 4, ¿system monitor¿, describes the pump flow display and the hazard alarms.This ifu states that the low flow hazard alarm will become active when pump flow is less than 2.5 liters per minute (lpm) and explains that changes in patient conditions can result in low flow.Section 7, "alarms and troubleshooting", describes all alarm conditions, including the low flow hazard alarm, as well as the appropriate actions associated with them.Section 5, ¿surgical procedures,¿ contains information regarding the preparation of the sealed outflow graft.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.¿ no further information was provided.The manufacturer is closing the file on this event.

Event Description

On (b)(6) 2021, a chest computerized tomography (ct) scan showed moderate size heterogeneous but hyperattenuating left pleural effusion, possibly representing hemothorax.Additionally, dilated loops of fluid filled the large and small bowel without focal transition point, likely representing ileus.Early on the morning of (b)(6) 2022 the patient had an acute clinical deterioration.They had evidence of what appeared to be pump malfunction with high pulse indices and powers in the 9-10 range respectively with flows of 2-2.5.This correlated with a rapid escalation in inotropic and pressor support.At one point, the patient was on 10 of epinephrine and greater than 40 of norepinephrine.They had profound metabolic acidosis and a profound lactic acidosis, and there was concern for chest bleeding.Echocardiography demonstrated significant biventricular dysfunction, left greater than right.There was clear evidence of pleural effusions bilaterally as well as pericardial fluid and clots.The patient's hemodynamics were marginal at best and the anesthesia team was blousing epinephrine and bicarbonate.The prior skin incision was opened.With mild separation of the sternum, there was an immediate rush of venous blood.A chest retractor was inserted.The bleeding was clearly coming from the vicinity of the superior vena cava (svc).Digital control was obtained and the bleeding was addressed with a series of pledgeted prolene sutures.The patient was markedly hypotensive secondary to hemorrhagic hypovolemic shock.The outflow graft was inspected from its insertion to the aorta to its insertion into the vad.There was a gentle twist to the outflow graft, but certainly nothing that would have explained pump dysfunction and outflow graft obstruction.The apex of the heart was elevated.There was no evidence of clot in the device itself.The lv apex was inspected.There was no evidence of clot in the left ventricle.There was no evidence of muscle that was at risk of being ingested into the device.The pump was then re-secured and returned to the chest.Of note, there were no flow abnormalities with the outflow graft or the inflow to the pump and there were no issues with flow, power spikes or elevations in the pulse index.Hemostasis was reasonable.Exploratory laparoscopy was also performed.This was converted to laparotomy due to evidence of dead bowel.A large amount of small bowel was resected.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) 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: 14471009
• MDR Text Key: 292383956
• Report Number: 2916596-2022-10769
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8077268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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): Required Intervention; Death
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American