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

Model Number 106524US

Device Problems Decreased Pump Speed (1500); Malposition of Device (2616); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Hemorrhage/Bleeding (1888); Ischemia (1942); Pleural Effusion (2010); Renal Failure (2041); Tachycardia (2095); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Respiratory Failure (2484); Thrombosis/Thrombus (4440); Cardiovascular Insufficiency (4445); Heart Failure/Congestive Heart Failure (4446); Gastrointestinal Hemorrhage (4476); Melena (4480); Liver Failure (4492)

Event Date 10/01/2022

Event Type  Injury  

Event Description

It was reported that the patient was implanted on (b)(6) 2022 with a heartmate 3 left venticular assist device (lvad) and a right ventricular assist device.The patient was taken back to the operating room to reposition the lvad.On (b)(6) 2022, the patient was reopened at the bedside and having continuous low flow alarms from (b)(6) 2022 23:11 to (b)(6) 2022 0:57 and multiple low speed advisory alarms.On (b)(6) 2022, there were concerns of inflow obstruction, and the patient experienced low flow alarms.A transesophageal echocardiogram (tee) was completed which showed left ventricular decompression and aortic valve opening.Hemodynamics and venous oxygen saturation were stable with no rise in lactate.The patient was brought back to the operating room and rvad outflow was switched to left atria with immediate improvement in flows.On (b)(6) 2022, low flows were captured between 3:51:35 to 4:05:11 and low speed advisories around 10:07:15 due to the low speed setting above the fixed speed setting.During this time, it appears that the fixed speed was being adjusted by the staff.The rvad was removed, and the speed was decreased to 5000.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that the patient had a history of type 2 diabetes mellitus, anemia, coronary disease, acute on chronic systolic, obesity, pulmonary hypertension, chronic obstructive pulmonary disease (copd), hypertension, left ventricular mural thrombus and chronic systolic heart failure with new york heart association class iii symptoms and was put on milrinone post intra-aortic balloon pump (iabp).On (b)(6) 2022, the patient was implanted with a heartmate 3 left ventricular assisted device (lvad) and percutaneous right ventricular assisted device (rvad).The patient experienced intermittent atrial fibrillation with rapid ventricular response (rvr) and supraventricular tachycardia (svt) and was treated with amiodarone and digoxin.On (b)(6) 2022, the patient was refractory to medical treatment and required cardioversion three times before converting back to sinus rhythm and also developed a right sided pleural effusion which was treated with a chest tube placement with good result.The patient continued to have extensive bleeding and loss of flows and on both (b)(6) 2022 and (b)(6) 2022 was taken back to the operation room (or) for exploration of post operative bleeding, lvad outflow repositioning and addition of an oxygenator to their rvad.They experienced continuous low flow alarms from (b)(6) 2022 and multiple low speed advisory alarms.The outflow graft was sutured to the chest wall.The patient was brought back to the operating room and rvad outflow was switched to left atria with immediate improvement in flows.On (b)(6) 2022, an additional cannula was added to the rvad to improve left sided filling in the setting of supra-systemic right sided pressures but on (b)(6) 2022 the cannula was removed.The patient continued to have ventilator dependent respiratory failure and on (b)(6) 2022 the patient went to the or for a tracheostomy.On (b)(6) 2022, low flows were captured between 3:51:35 to 4:05:11 and low speed advisories around 10:07:15 due to the low speed setting above the fixed speed setting.A transesophageal echocardiogram (tee) was completed with left ventricular decompression and atrioventricular opening that revealed effusion and resulted in a pericardial window on (b)(6) 2022.The effusion was found to be very small and no further intervention was performed.Hemodynamics and venous oxygen saturation were stable with no rise in lactate.The patient's post operative course was complicated by persistent right ventricular failure, acute kidney injury (aki) on chronic kidney disease resulting in slow continuous ultrafiltration (scuf), continuous veno-venous hemodialysis (cvvhd), gastrointestinal (gi) bleeding and ischemic stomach.Gi was consulted for melena, an endoscopy was performed and on (b)(6) 2022, it was revealed that the patient had a clot in their stomach but no active bleeding.The patient received blood products and anticoagulation was held.The patient began having melena again and gi was re-consulted.An endoscopy was performed on (b)(6) 2022 which revealed extensive ischemic areas in the stomach.A computed tomography angiography (cta) was performed which revealed celiac axis occlusion with some collaterals.General surgery was consulted for possible gastrectomy, however, in the setting of multi-organ failure (kidney, liver, lung, bladder), cardiogenic shock, acute rheumatic fever (arf) on continuous renal replacement therapy (crrt), and shock liver with high levels of bilirubin, it was determined that her surgical risk was extremely high and after discussion with family the decision was made to defer further surgical plans.On (b)(6) 2022, the patient's rvad was decannulated at beside.A heparin drip was started but the patient continued to have gi bleeding and anticoagulation held again.The patient's liver enzymes continued to rise dramatically and she continued to be in multi-pressor shock.On (b)(6) 2022, the patient as put on comfort care and their lvad was turned off at (b)(6)and they passed away at (b)(6).Additional procedures included arterial line, swan ganz catheter, internal jugular line, bronchoscopy.Additional departments consulted were cardiology, nephrology, hematology/oncology and palliative care.

Manufacturer Narrative

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

Event Description

It was reported that the outflow graft was sutured to the chest wall after outflow graft malposition was identified to be the cause of low flows.As of (b)(6) 2022, the patient was in critical condition and is on vasopressors, continuous venovenous hemodialysis (ccvhd) and remains intubated.The right ventricular assist device (rvad) been implanted (b)(6) 2022 for rv support following left ventricular assist device (lvad) implant.

Manufacturer Narrative

Manufacture¿s investigation conclusion: a direct correlation between the device and the reported events could not be conclusively established through this evaluation.Review of the submitted log files confirmed low flow alarms.Although a specific cause for the low flow events could not be conclusively determined through this evaluation, the account later communicated that they were likely attributed to outflow graft malposition.A specific cause for the reported malposition could not conclusively be determined through this evaluation.The submitted system controller event log files captured low flow alarms on 01oct2022, 02oct2022, and 06oct2022.No other notable events were observed and the pump appeared to have operated as intended at the set speed.The device was not explanted and was not returned for evaluation.The heartmate 3 left ventricle assist system (lvas) instructions for use (ifu) is currently available.Section 1, "introduction," lists bleeding, cardiac arrhythmia, thromboembolism, various types of organ failure (right heart, respiratory, renal, and hepatic failure), and death as adverse events which may be associated with the use of heartmate 3 lvas.Section 4, ¿system monitor,¿ explains that the low flow hazard alarm occurs when pump flow is less than 2.5 liters per minute (lpm).A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.Changes in patient conditions can result in low flow.Section 5, "surgical procedures," provides an image of the proper pump implantation configuration and discusses implanting and orienting the outflow graft.This section cautions: "the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component or body structure." section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Section 7, ¿alarms and troubleshooting,¿ explains all system alarms and the recommended actions associated with them.The heartmate 3 lvas patient handbook also outlines all system controller alarms as well as how to respond to each alarm condition.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.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 (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: 15589013
• MDR Text Key: 301589994
• Report Number: 2916596-2022-14295
• 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,Followup,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8547428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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): Hospitalization; Death; Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: Black Or African American