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 Problem Hemorrhage/Bleeding (1888)

Event Date 07/02/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(4), and the reported bleed could not conclusively be established through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(4).No further related events have been reported at this time.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2021.The heartmate 3 left ventricular assist system (lvas) instruction for use (ifu) is currently available.Section 1 of this document lists bleeding as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 ¿patient care and management¿ (under "anticoagulation") outlines the recommended anticoagulation regimen (including international normalized ratio (inr) range) for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications in the event that there is a risk of bleeding.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient experienced oral bleeding after a recent tooth extraction.The patient presented to the emergency room and was transfused with 2 units of packed red blood cells (prbcs).The patient was later discharged.

• 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: 15090502
• MDR Text Key: 296467647
• Report Number: 2916596-2022-12337
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8229073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 54 KG