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

Model Number 106015

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 01/31/2024

Event Type  Injury  

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 patient was admitted with complain of chest pain and shortness of breath.Pump clot was confirmed via ramp echocardiogram (echo).Lactate dehydrogenase (ldh) was 503 on (b)(6) 2024; no other labs or imaging were done.There were no unusual events recorded in the log file event history.The patient was still inpatient at the time.

Event Description

It was reported that the patient was admitted with a complaint of chest pain and shortness of breath.The patient¿s lactate dehydrogenase (ldh) level was 503 on (b)(6) 2024.Initially, the chest pain and shortness of breath was attributed to a suspected pump clot.A ramp echocardiogram (echo) was ordered to rule out thrombosis.It was reported that the patient would remain inpatient at the time.It was later reported that the ramp study results were inconclusive; a right heart catheterization was then performed showing normal filling pressures, leading to low suspicion for pump thrombus.Ultimately, pump thrombus could not be confirmed, and the cause of the reported events is unknown.The patient would continue to be monitored and remain on anticoagulation per protocol.

Manufacturer Narrative

Manufacturer's investigation conclusion: the suspected device thrombosis could not be confirmed through this evaluation.A direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established through this evaluation.Additionally, a direct correlation between the reported events and the suspected thrombus could not be conclusively established.The submitted log files collectively contained data and events from 24jan2024 ¿ 31jan2024 and 01feb2024 ¿ 07feb2024.No notable events or alarms were captured.The pump appeared to function as intended at the fixed speed throughout the duration of the file.The patient remains ongoing on heartmate ii lvas, serial number (b)(6), and no further related events have been reported at this time.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 ii lvas instructions for use (ifu), rev.C, is currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including device thrombosis and hemolysis, that may be associated with the use of the heartmate ii lvas.The patient care and management section of the ifu outlines the indications of thrombus and how to respond to such events.This document also provides the recommended anticoagulation regimen, as well as suggested anticoagulation modifications.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18746808
• MDR Text Key: 335865688
• Report Number: 2916596-2024-00768
• Device Sequence Number: 1
• Product Code: DSQ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model 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: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• 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): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 83 KG