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

Model Number 106015

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hematoma (1884); Hemothorax (1896); Pleural Effusion (2010); Tachycardia (2095); Ventricular Fibrillation (2130); Syncope/Fainting (4411); Aortic Valve Insufficiency/ Regurgitation (4450); Tricuspid Valve Insufficiency/ Regurgitation (4453); Pulmonary Hypertension (4460)

Event Date 06/02/2022

Event Type  Injury  

Event Description

It was reported that the patient was found unresponsive at home after having large black stool.The patient was given bolus by the first responders and brought to the emergency department (ed) with improved mental status, but then quickly decompensated requiring cpr and then multiple shocks for ventricular fibrillation.The patient was given intravenous (iv) amiodarone, levophed, lidocaine, and was intubated.Gastrointestinal (gi) bleeding was not confirmed and the guaiac was negative.On (b)(6) 2022, an echo showed a mildly enlarged right ventricle (rv) with reduced systolic function, mild tricuspid regurgitation, and mild pulmonary hypertension.The aortic valve did not seem to open with each cardiac cycle, and mild aortic regurgitation was present.At the time, the patient was status post cardiac arrest that they had at the ed.On (b)(6) 2022 an abdominal computerized tomography (ct) scan revealed a heterogenous intrahepatic hematoma measuring up to 13 cm (measured 6 cm on (b)(6) 2022 and involved most of the left lobe as well as demonstrated active extravasation with moderate to large volume hemoperitoneum.Also noted were multiple hypodensities in the spleen some which were peripheral and wedge-shaped concerning for multiple splenic infarcts.That same day, a chest ct revealed interval increase in size of the moderate volume layering bilateral effusions which were thought to be hemothorax due to the fractured ribs resulting from the fall.Mild interstitial edema was also present, as well as evidence of non ischemic cardiomyopathy.The patient reportedly had no history of ventricular tachycardia/fibrillation, and had no history of implanted cardioverter defibrillator use.The log file review captured multiple low flow alarms on the morning of the fall.These events seemed to be due to patient condition and were not device related.The low flows were reportedly due to volume depletion as a result of decreased po intake.The patient was given epinephrine and lidocaine, as well as shocks and fluid expansion.The patient reportedly experienced altered mental status throughout this event.

Manufacturer Narrative

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

Event Description

It was later communicated that the patient had further low flows as well as heartrate in the 60s.The patient was being worked up for biventricular pacemaker.It was reported that the cause of the low flows was recurrent ventricular tachycardia (vt) and ventricular fibrillation.The patient experienced fatigue and altered mental status, as well as needing to be emergently intubated with initiation of amiodarone and levophed.The patient did not have a history of arrhythmia prior to ventricular assist device (vad) implant.On (b)(6) 2022, a dual chamber implantable cardioverter-defibrillator (icd) was implanted for secondary sudden cardiac death prevention and for pacing requirement.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (lvas) and the reported event could not conclusively be established through this evaluation.Furthermore, an analysis of the log file provided by the account confirmed low flow alarms.According to the account, the low flow alarms were due to ventricular fibrillation (v-fib) and volume depletion.The submitted log file contained events from (b)(6) 2022 through (b)(6) 2022.The file captured low flow events throughout the majority of the file.The pump appeared to be functioning as intended, remaining above the low speed limit for the duration of the file.The patient remains ongoing on heartmate ii lvas.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 (b)(6) 2014.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this document lists bleeding, cardiac arrhythmia, and neurological dysfunction as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Pump speed, power, flow, and pulsatility index (pi) are also addressed in section 1 of this ifu.Section 4 provides more information regarding all pump parameters and also describes situations which may result in a low flow hazard alarm.Section 6 "patient care and management" explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling, explains that pump flow is estimated from pump power, and addresses assessing pump flow.Section 5 of the ifu, ¿surgical procedures¿, warns that moderate to severe aortic insufficiency must be corrected at the time of device implant.This section of the ifu also warns that patients with mitral or aortic mechanical valves may be at added risk of accumulating thrombi on the valve when supported with left ventricular assist devices.Section 6 also outlines the suggested anticoagulation regimen and international normalized ratio (inr) range that should be maintained for patients using the heartmate ii lvas as well as the suggested anticoagulation modifications in the event there is a risk of bleeding.Section 6 entitled ¿patient care and management¿ also lists arrhythmia and neurological dysfunction as a potential late postimplant complication.Section 6 also lists pulmonary hypertension as a potential risk/adverse event that may be associated with the use of heartmate ii lvas and states that post-implantation hypertension may be treated at the discretion of the attending physician.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions including the low flow hazard as well as the appropriate actions associated with them.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 (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: 14754016
• MDR Text Key: 294782651
• Report Number: 2916596-2022-11512
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 85 KG