BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 7131682 · Received December 19, 2017

    Report

    Report Number
    2916596-2017-03233
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    November 5, 2017
    Report Date
    April 10, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: RAHATULLAH MUSLEM, KADIR CALISKAN, SAKIR AKIN,KAVITA SHARMA, NISHA A. GILOTRA, ALINA A. CONSTANTINESCU, BRIAN HOUSTON, GLENN WHITMAN, RYAN J. TEDFORD, DENNIS A. HESSELINK, AD J.J.C. BOGERS, STUART D. RUSSELL, OLIVIER C. MANINTVELD. CIRCULATION: JOURNAL OF HEART AND LUNG TRANSPLANTATION, HTTPS://DOI.ORG/10.1016/J.HEALUN.2017.11.005 , 2017, STATING: ¿ACUTE KIDNEY INJURY AND 1-YEAR MORTALITY AFTER LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION ACUTE KIDNEY INJURY AFTER LVAD IMPLANTATION¿ THE LOCATION OF THE DEVICES, NUMBER OF DEVICES AND NUMBER OF PATIENTS RELATED TO HEARTMATE IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A DIRECT CORRELATION BETWEEN THE IMPLANTED HEARTMATE II DEVICES AND THE REPORTED ACUTE RENAL INJURY INCIDENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. SPECIFIC DEVICE, INCIDENT, AND PATIENT INFORMATION WERE NOT AVAILABLE THROUGH THE ARTICLE; HOWEVER, RENAL FAILURE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS DEVICE SERIAL NUMBERS WERE NOT AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    A LITERATURE ARTICLE WAS RECEIVED: ACUTE KIDNEY INJURY (AKI) IS A HIGHLY FREQUENT COMPLICATION AFTER CONTINUOUS FLOW LEFT VENTRICULAR ASSIST DEVICE (CF-LVAD) IMPLANTATION AND THAT AKI ADVERSELY AFFECTS EARLY AND LONG-TERM RENAL FUNCTION AND SURVIVAL OF CF-LVAD PATIENTS DURING THE FIRST YEAR. THE ASSOCIATION WITH MORTALITY IS STRONGLY RELATED TO THE SEVERITY OF AKI. PREVENTION OR MITIGATION OF THE SEVERITY OF AKI AFTER CF-LVAD IMPLANTATION SHOULD THEREFORE BE AN IMPORTANT GOAL OF PERI-OPERATIVE CARE. ONE CAN SEE THAT IT IS THE PATIENTS EXPERIENCING NO AKI OR AKI STAGE I THAT HAD SIGNIFICANTLY IMPROVED RENAL FUNCTION AT ONE YEAR AFTER IMPLANTATION COMPARED TO BASELINE, WHILE THOSE WITH AKI STAGE II AND III DID NOT HAVE ANY SIGNIFICANT IMPROVEMENT IN RENAL FUNCTION. THIS COULD BE DUE TO THE INTRINSIC RENAL DAMAGE SUFFERED BY THESE PATIENTS BEFORE CF-LVAD IMPLANTATION OR IN THE PERI-OPERATIVE PERIOD, WHICH SEEMS TO BE IRREVERSIBLE IN THESE PATIENTS. HOWEVER, OUR STUDY IS LIMITED DUE TO THE LOW NUMBER OF SURVIVORS IN THE AKI STAGE II AND III GROUPS. TWO HUNDRED FIFTY ONE PATIENTS UNDERWENT CF-LVAD IMPLANTATION BETWEEN (B)(6) 2004 AND (B)(6) 2015 AT (B)(6). THE CF-LVADS WERE EITHER A HEARTMATE II ((B)(6)) OR A HEARTWARE (HEARTWARE INTERNATIONAL INC.) DEVICE. OF WHICH 241 PATIENTS WERE INCLUDED FOR FURTHER ANALYSIS. TEN PATIENTS WERE NOT INCLUDED BECAUSE THEY WERE YOUNGER THAN 18 YEARS (N = 7) OR DIED WITHIN 48 HOURS FOLLOWING CF-LVAD IMPLANTATION (N = 3). 65 PATIENTS (27%) DIED DURING THE FIRST YEAR AFTER CF-LVAD IMPLANTATION. THE MOST FREQUENT CAUSE OF DEATH WAS NON-CARDIAC (58.5%) FOLLOWED BY CARDIAC (38.5%). IN TWO (3.1%) PATIENTS THE CAUSE OF DEATH WAS UNDETERMINED. THIS REPORT CAPTURES THE ACUTE RENAL INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908525 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R