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

Model Number 106524US

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Left Ventricular Dysfunction (1947); Right Ventricular Dysfunction (2054); Blood Loss (2597); Ischemia Stroke (4418)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020 the patient experienced a post-operative ischemic stroke.Low flow alarms were also recorded.The patient was given heparin during the procedure and was partially reversed with protamine due to concerns for bleeding at the operative site.The patient also received platelets and the plan was to start aspirin and heparin the morning after, giving the site time to heal.A ramp echo revealed severely reduced left ventricle function.No acoustic windows were available.Pump speed was decreased from 5200 rpm to 5000 rpm due to multiple low flow alarms and pulsatility index (pi) events.There were two re-openings for bleeding.The patient was intubated and put on continuous renal replacement therapy (crrt) and nitric for severe right ventricle dysfunction.The patient would be monitored regarding the need for temporary right ventricle support.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported stroke, right heart failure, bleeding and renal dysfunction could not be conclusively determined.Additionally, the reported low flow alarms could not be confirmed as no log files were submitted for evaluation; a cause for the reported alarms could also not be determined.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No additional related events have been reported at this time.The heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu) section 1 ¿introduction¿ of this document lists the adverse events that may be associated with the use of heartmate 3 lvas, including stroke, bleeding, right heart failure, and renal dysfunction.It also explains that pump flow is a calculated value that is estimated based on pump power, and also provides an explanation of all pump parameters, including pump flow.This section also explains that the pulsatility index (pi) is a calculation that represents cardiac pulsatility, and describes that pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events are also referred to as pi events, and may be initiated for reasons other than true pi events.Section 4 "system monitor" provides information about the pump flow display and the low flow hazard alarm.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm, and also explains that changes in patient conditions can result in low flow.It also states that pi events are caused by sudden and substantial changes in pi and involve the pump speed dropping to the low speed limit before slowly ramping up to the fixed speed.Section 6 ¿patient care and management¿ states that right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump.It also lists typical treatment options.This section also provides information regarding anticoagulation, including recommended international normalized ratio (inr) values, and the suggested anticoagulation modifications in the event there is a risk of bleeding.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Heartmate 3 lvas patient handbook: section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11116305
• MDR Text Key: 225052474
• Report Number: 2916596-2020-06431
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7026965
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention