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

Model Number 106524US

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Thrombosis (2100); Blood Loss (2597); Thrombosis/Thrombus (4440); Gastrointestinal Hemorrhage (4476)

Event Date 11/04/2019

Event Type  Injury  

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 was off anticoagulation and aspirin due to a history of gastrointestinal bleeding and an intrathoracic bleed/mediastinal hematoma.The intrathoracic bleed/mediastinal hematoma required re-exploration and evacuation of a clot around the outflow graft on (b)(6) 2019 during the patient's index hospitalization.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported bleeding could not be conclusively established through this evaluation.The patient remained ongoing on heartmate 3 lvas, serial number (b)(6) until they expired on (b)(6) 2020 due to a cerebrovascular accident (reported under mfr # 2916596-2020-05420).No product is available for investigation.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 02oct2019.The heartmate 3 lvas ifu, rev.C, is currently available.Section 1 of this ifu lists bleeding as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system.This document also provides information regarding anticoagulation, including recommended inr values.The heartmate 3 lvas ifu lists bleeding as an adverse event that may be associated with the use of heartmate 3 lvas.This document also provides information regarding anticoagulation, including recommended inr values, and 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.

• 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: 11067288
• MDR Text Key: 223475570
• Report Number: 2916596-2020-06470
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7172927
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 74