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

Model Number 106524US

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Thromboembolism (2654); Thrombosis/Thrombus (4440)

Event Date 01/03/2022

Event Type  Injury  

Event Description

It was reported that an echocardiogram revealed a possible aortic leaflet thrombus and an arterial peripheral thromboembolism.The plan was for target inr (international normalized ratio) to be slightly elevated at 2.5.

Manufacturer Narrative

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

Event Description

The patient's antithrombotic medication would be intensified.

Manufacturer Narrative

Manufacturer's investigation conclusion: the relevant sections of the device history record for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (hm 3 lvas) instructions for use (ifu) is currently available.Section 1, ("introduction") lists potential adverse events that may be associated with the use of the hm3 lvas, including thrombus and arterial peripheral thromboembolism.Section 6, (¿patient care and management¿), lists potential late postimplant complications that may be associated with the use of the hm3 lvas, including thromboembolism, as well as provides information regarding anticoagulation, including the recommended international normalized ratio (inr) values.A direct correlation between the reported thrombus and heartmate 3 (hm3) left ventricular assist device (lvad) serial number (b)(6) could not be conclusively determined through this evaluation.The patient remains ongoing with heartmate 3 left ventricular assist system, serial number (b)(6), and no product is available for investigation.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
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13208134
• MDR Text Key: 286526876
• Report Number: 2916596-2022-00124
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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: Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8129962
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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; Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 77 KG