MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

Device Problem Obstruction of Flow (2423)

Patient Problems Edema (1820); Thrombus (2101); Heart Failure (2206); Obstruction/Occlusion (2422)

Event Date 11/13/2020

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

It was reported that the patient was admitted with clinical signs and symptoms for thrombus.The patient had erratic international normalized ratio (inr) and elevated plasma hemoglobin of 73.7 on (b)(6) 2020.However, lactate dehydrogenase (ldh) ranged only from 230-432.The patient was non-compliant with warfarin and there were no changes to pump parameters.An echocardiogram was done on (b)(6) 2020 and did not report clear obstruction to flow.There were no significant events on interrogation of device.Technical services reviewed the log file and found no unusual events recorded.The device was operating as intended.The patient was fluid overloaded and underwent diuresis with iv (intravenous) medications.The patient remained hospitalized with worsening right heart failure (rhf), acute on chronic renal and liver dysfunction, and concern for thrombus.

Manufacturer Narrative

Section d4: the heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing momentum 3 trial.The gtin unique device identifier for the commercial heartmate 3 system controller is (b)(4).Manufacturer's investigation conclusion: the report of suspected thrombus could not be confirmed through this investigation, as no product or images were submitted.Additionally, a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events (suspected thrombus, right heart failure, hepatic failure, and renal failure) could not be conclusively established.It was reported that the patient was admitted with clinical signs and symptoms for thrombus.Review of the submitted log file revealed no unusual events.The system appeared to be operating as intended.It was later reported that the patient was non-compliant with anticoagulation medication and had erratic international normalized ratio (inr) values, as well as elevated plasma hemoglobin.An echocardiogram revealed no flow obstructions.The patient was being treated for fluid overload with intravenous medications and remained hospitalized with worsening right heart failure, renal and liver dysfunction, and concern for thrombus.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).The heartmate 3 lvas instructions for use (ifu) lists thromboembolism, right heart failure, renal dysfunction, and hepatic dysfunction as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This ifu outlines the indications of thrombus as well as how to respond to such events.This document also provides information regarding the recommended anticoagulation therapy and inr range.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 ¿introduction¿ of this document lists pump thrombosis, right heart failure, renal dysfunction, and hepatic dysfunction as adverse events that may be associated with the use of heartmate 3 lvas.Section 6, ¿patient care and management¿, also lists thromboembolism as a potential late postimplant complication.Additionally, this section, under ¿anticoagulation¿, provides the recommended anticoagulation regimen, including international normalized ratio (inr) values, as well as suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10955821
• MDR Text Key: 219867045
• Report Number: 2916596-2020-05989
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 106524
• Device Lot Number: 6470295
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 155