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 Death (1802); Heart Failure (2206); Respiratory Failure (2484); Blood Loss (2597)

Event Date 12/05/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient was to be placed on venoarterial extracorporeal membrane oxygenation (va ecmo) for increased hemodynamic support.On the system monitor a 4 hour extended alarm silence setting was applied in preparation for the ecmo.The patient had right heart failure and bleeding that contributed to hemodynamic instability.The patient also had low flow.It was reported that the patient passed away on (b)(6) 2020 and that progressive heart and respiratory failure were the cause of death.An autopsy decision was pending.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the report of right heart failure, respiratory failure, and bleeding could not be conclusively established through this evaluation.Additionally, the reported low flows could not be confirmed through this investigation, and a specific cause for the low flows could not be determined.Per the ventricular assist device (vad) coordinator, the device will not be returned for evaluation.The heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu) lists bleeding, respiratory failure, right heart failure, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document also provides information regarding anticoagulation, including recommended inr values, and the suggested anticoagulation modifications in the event that there is a risk of bleeding.The ifu explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and notes that changes in patient conditions can result in low flow.This ifu also describes all system alarms and the recommended actions associated with them.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped to the customer on 13aug2020.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: 11069174
• MDR Text Key: 223575781
• Report Number: 2916596-2020-06286
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7596393
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 114