MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Right Ventricular Dysfunction (2054); Thrombosis (2100); Tricuspid Regurgitation (2112)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 left ventricular assist system (lvas) was implanted during the (b)(6) clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23aug2017.The gtin unique device identifier for the commercial heartmate 3 lvas is (b)(4).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Event details: the patient was implanted with lvad on (b)(6) 2018.Postoperatively, the patient had moderate right ventricular (rv) dysfunction and was placed on high dose inotropes.Post-implant echocardiogram revealed severe tricuspid regurgitation (tr).Post op course complicated by significant bleeding, the chest tube output was over 1500 ml.The patient required blood transfusion.On (b)(6) 2018, the patient underwent mediastinal re-exploration for bleeding/thrombosis and tricuspid valve repair.The patient had leukocytosis and was treated with vancomycin and cefepime for open chest prophylaxis.Pan cultures obtained and all came back negative on (b)(6) 2020.No further information was reported.

Manufacturer Narrative

Section b2: correction.Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to heartmate 3, serial number (b)(6), could not conclusively be determined through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6), and the percutaneous lead were reviewed and showed no deviations from manufacturing or qa specifications.The current heartmate 3 lvas ifu lists right heart failure, bleeding, and localized infection as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.The ifu also cautions the user that right heart failure can occur following implantation of the pump and outlines the associated treatment options, including rvad placement, and also provides information regarding anticoagulation, including the recommended inr values.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was found to have sever tricuspid valve regurgitation on the echocardiogram.The patient was taken back to the operating room (or) and the valve was repaired.A repeat echo showed trivial regurgitation.Post-lvad implant the patient became febrile with leukocytosis.The patient experienced significant bleeding, chest-tube output greater than 1500cc, post-operatively.During hospital duration the patient received 4 units of packed red blood cells and one unit of flash frozen plasma.The patient was taken back to the or for a chest washout due to and closure.Samples obtained came back negative for growth.The patient was started on iv antibiotics, cefuroxime and vancomycin.Repeat cultures resulted positive for rare gram negative rods and positive cocci.The patient completed an antibiotic regime on (b)(6) 2019.The patient remained in hospital due to elevated white blood cell count.The patient was administered a dosage of milrinone, epinephrine and dopamine infusions due to worsening heart failure symptoms.The patient was discharged home on (b)(6) 2018 in stable condition.The patient had no further signs of bleeding and all cultures remained negative with hemoglobin was 10.3 g/dl and hematocrit was 33.8% at discharge.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10528804
• MDR Text Key: 206781972
• Report Number: 2916596-2020-04592
• Device Sequence Number: 1
• Product Code: DSQ
• 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,study
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 106524
• Device Lot Number: 6252687
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 11/03/2020
• Supplement Dates FDA Received: 10/22/2020; 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 65