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

Model Number 106524US

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/11/2022

Event Type  Injury  

Event Description

It was reported that a thrombus in the left ventricle was found in an echocardiogram.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the suspected arteriovenous thrombus could not be confirmed as no images or log files were provided by the account and the device was not returned for evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).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), rev.B, is currently available.Section 1 of the ifu, "introduction," lists potential adverse events, including venous thromboembolism and arterial non-central nervous system (cns) thromboembolism, which may be associated with the use of heartmate 3 lvas.Section 6 lists thromboembolism as a potential late post-implant complications that may be associated with the use of the heartmate 3 left ventricular assist system.Information regarding recommended anticoagulation therapy and international normalized ratio range is also provided in this section.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was asymptomatic but showed signed so arteriovenous (av) thrombus.It was noted that there were no recent changed to pump parameters.Heparization was conducted and the thrombus resolved on (b)(6) 2022.

• Brand Name: 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: 18759841
• MDR Text Key: 336011921
• Report Number: 2916596-2024-00892
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/05/2024
• Device Model Number: 106524US
• Device Lot Number: 8482705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 60 KG