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

Model Number 106524US

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

Patient Problems Arrhythmia (1721); Hemolysis (1886)

Event Date 10/19/2023

Event Type  Injury  

Event Description

It was reported that patient previously had episodes of ventricular tachycardia (vt) and a speed decreased from 5200 to 5000rpm, but the night before, (b)(6) 2023, they had 3 more episodes.The next morning¿s interrogation noted speed drops and low speed advisory and the patient had some hemolysis on morning labs, so it was suspected there was pump suction.Log file captured on (b)(6) 2023, some low flow events.The calculated flow appeared to have fluctuated below the alarm threshold of 2.5 lpm.Also, on (b)(6) 2023, it was noted low speed advisories related to the set speed being below the low-speed setting.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between device and the reported cardiac arrhythmia and hemolysis could not conclusively be determined through this evaluation.The submitted log files captured the pump operating as intended at the set speed.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no further information was provided.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).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 3 left ventricle assist system (lvas) instructions for use (ifu), rev.C is currently available.Section 1, "introduction," lists cardiac arrhythmia and hemolysis (not associated with suspected device thrombosis) as adverse events which may be associated with the use of heartmate 3 lvas.Section 6, ¿patient care and management," lists arrhythmia as a potential late postimplant complication.Under ¿anticoagulation", this section provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was planned to get limited echocardiogram and have ventricular tachycardia (vt) managed medically.

Manufacturer Narrative

Section d3, g1: updated information.Section d1: corrected.Section d4, lot number: corrected.Section d4, primary udi number: corrected.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18086890
• MDR Text Key: 327589093
• Report Number: 2916596-2023-07585
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: (01)00813024013297(21)MLP-040139(17)250303
• 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: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 9243679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/30/2024; 05/13/2024
• Supplement Dates FDA Received: 01/30/2024; 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2023
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American