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

Model Number 106524US

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

Patient Problems Stroke/CVA (1770); Death (1802); Hemorrhage, Subdural (1894)

Event Date 10/21/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a fall at home on (b)(6) 2020.The patient was on coumadin and a computed tomography (ct) scan showed a large subdural hematoma.The patient was taken to the operating room emergently for a craniotomy by neurosurgery.They never regained consciousness from the neurological event and patient care was removed per family request.The patient was pronounced deceased on (b)(6) 2020.

Manufacturer Narrative

Section a4: additional information.Manufacturer's investigation conclusion: a direct correlation between the reported subdural hematoma and heartmate 3 left ventricular assist system (lvas) cannot be conclusively established through this evaluation.The heartmate 3 lvas instructions for use (ifu) lists bleeding as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.In addition, this document outlines the recommended anticoagulation regimen for patients using the device as well as the suggested anticoagulation modifications in the event there is a risk of bleeding.The relevant sections of the device history records for (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.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
• MDR Report Key: 10895320
• MDR Text Key: 217981248
• Report Number: 2916596-2020-05547
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6930101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 91