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 Aortic Insufficiency (1715); Heart Failure (2206)

Event Date 11/01/2014

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event is approximate as the data was collected between november 2014 and march 2019.Specific patient information and device serial number are documented as unknown.The device was implanted at the time of event.The author is listed as, a malick, et al.Journal of heart and lung transplantation, volume: 39, issue: 4, pages: s406-s407.Doi: 10.1016/j.Healun.2020.01.160; department of surgery, division of cardiothoracic surgery, (b)(4) medical center, (b)(4).No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported through the research abstract ¿development of de novo aortic insufficiency in patients with heartmate 3¿ identifying that the hm3 is related with readmissions due to aortic insufficiency (ai) and heart failure symptoms.This study assessed the incidence and outcomes of de novo ai in hm3 patients.This retrospective study included 151 hm3 patients implanted between nov 2014 and march 2019, and the clinical characteristics and serial echocardiograms (1 month, 6 months, and 1 year post implant) were evaluated.De novo ai was defined as more than mild ai.4 patients were readmitted due to significant ai and heart failure symptoms.Cumulative incidence curves showed that the probability of de novo ai at 1 year was 8.4%.Patients who had av opening on echocardiogram at 1 month post implant were significantly less likely to develop de novo ai (100% freedom from de novo ai at 1 year with open av vs.84% with closed av).

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the heartmate 3 devices and the reported aortic insufficiency could not be conclusively determined through this evaluation.The heartmate 3 device serial numbers, as well as other specific case/patient information, are not available.The heartmate 3 lvas ifu and the heartmate 3 lvas patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 5 of the ifu, ¿surgical procedures¿, warns that moderate to severe aortic insufficiency must be corrected at the time of device implant.If not addressed, the lvad will not be able to provide the intended flow.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: 11050419
• MDR Text Key: 223721852
• Report Number: 2916596-2020-06037
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other