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

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Respiratory Failure (2484); Thrombosis/Thrombus (4440)

Event Date 06/30/2022

Event Type  Death  

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 on (b)(6) 2022 the patient's intra operative course was complicated by bleeding (coagulopathy) and vasoplegia which was treated with blood products and factor viii and it resolved without sequelae on (b)(6) 2022.On (b)(6) 2022, the patient was reintubated due to worsening status, labored breathing, tachypnea, and difficulty clearing secretions.On (b)(6) 2022, the patient also had upper extremity swelling and ultrasound revealed an occlusive deep vein thrombosis throughout the left internal jugular vein and the more inferior subclavian vein.In addition, there was an occlusive superficial thrombus throughout the basilic and cephalic veins.On (b)(6) 2022, the patient had a supratheraputic international normalized ratio of 8.5 and 5.2 which stopped the same day.On (b)(6) 2022, it was reported that the patient passed away.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the patient outcome could not be conclusively determined through this evaluation.A direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events and patient outcome could not be conclusively established through this evaluation.Multiple requests for additional information regarding this event were submitted to the account; no response has been received at this time.(b)(6) was not returned for evaluation.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 bleeding, respiratory failure, venous thromboembolism, and death as adverse events that may be associated with the use of the heartmate 3 lvas.Additionally, section 6 ¿patient care and management¿ provides information regarding the recommended anticoagulation therapy and inr (international normalized ratio) range, as well as considerations for when there is a risk of bleeding.Section 6 also outlines indications of thrombus as well as how to respond to such events.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 (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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15058242
• MDR Text Key: 296207373
• Report Number: 2916596-2022-12363
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/12/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8495261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2022
• 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): Death; Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Race: White