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 Right Ventricular Dysfunction (2054); Blood Loss (2597)

Event Date 05/21/2020

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 patient was implanted on (b)(6) 2020.Patient returned to operating room (or) on (b)(6) 2020 for exploration.A tear in left ventricle was noted and repaired with bioglue.Patient was taken back to or on (b)(6) 2020 for chest closure and centrimag weaned and removed on (b)(6) 2020.Patient was successfully discharged on (b)(6) 2020.Additional information states that centrimag was implanted on (b)(6) 2020 (same day as lvad without leaving or), but was implanted after the vad was implanted and turned on due to gradual escalation in central venous pressure (cvp) as well as septal shift and right ventricle (rv) dilation following lvad implant.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between the device and the reported bleeding and right heart failure symptoms could not be conclusively determined through this evaluation.The account reported that the patient experienced bleeding after implantation of the pump.The patient returned to the operating room (or) and a left ventricular tear was observed and repaired with bioglue.The patient also experienced a gradual escalation in central venous pressure (cvp), a septal shift, and right ventricular dilation following left ventricular assist device (lvad) implant leading to implantation of a centrimag.The centrimag was weaned and removed on (b)(6) 2020.The patient remains ongoing on vad support with no further issues reported.Review of the device history records showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped to the customer on (b)(6)2020.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists bleeding and right heart failure as adverse events that may be associated with the use of heartmate 3 lvas.This document provides information regarding anticoagulation, including recommended international normalized ratio (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: 10283474
• MDR Text Key: 200056371
• Report Number: 2916596-2020-03462
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7441279
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2020
• 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: 76