BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14497710 · Received May 25, 2022

    Report

    Report Number
    2916596-2022-11215
    Event Type
    Death
    Date Received
    May 25, 2022
    Date of Event
    March 31, 2017
    Report Date
    August 15, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. ARTICLE TITLE: EVOLUTION OF LATE RIGHT HEART FAILURE WITH LEFT VENTRICULAR ASSIST DEVICES AND ASSOCIATION WITH OUTCOMES. J. EDUARDO RAME ET AL. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 78, NO. 23, 202, HTTPS://DOI.ORG/10.1016/J.JACC.2021.09.1362. CARDIOVASCULAR MEDICINE, (B)(6). ADDITIONAL MFR # 2916596-2022-11213. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION B2: SPECIFIC DATES OF DEATH ARE UNKNOWN. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SPECIFIC INFORMATION REGARDING THE EXPIRED PATIENTS, AS WELL AS HEARTMATE 3 DEVICE SERIAL NUMBERS, IS NOT AVAILABLE. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) MAY BE RELATED TO RIGHT HEART FAILURE (RHF), DEATH, PUMP THROMBOSIS, INFECTION, GASTROINTESTINAL BLEEDING, STROKE AND UNKNOWN TRANSPLANT THROUGH THE RESEARCH ARTICLE TITLED ¿EVOLUTION OF LATE RIGHT HEART FAILURE WITH LEFT VENTRICULAR ASSIST DEVICES AND ASSOCIATION WITH OUTCOMES." OF THE 1,070 PATIENTS WHO HAD LESS THAN 3 MONTHS OF FOLLOW-UP, 654 (61%) DIED, 174 (16%) WERE TRANSPLANTED, 20 (2%) HAD CESSATION OF SUPPORT, 196 (18%) HAD A DEVICE EXCHANGE, AND 26 (2%) WERE ALIVE ON SUPPORT. OF THE 287 PATIENTS WHO DID NOT HAVE A FOLLOW-UP FORM AT 3 MONTHS, 18 (6%) DIED, 34 (12%) WERE TRANSPLANTED, 6 (2%) HAD CESSATION OF SUPPORT, 14 (5%) HAD A DEVICE EXCHANGE, AND 215 (75%) WERE ALIVE ON SUPPORT. ASSESSMENTS FOR THE CONDITION OF RHF WERE PERFORMED AT 1 WEEK, 1 MONTH, 3 MONTHS, AND 6 MONTHS, AND 1 YEAR AFTER IMPLANT TO DETERMINE INCIDENCE OF RHF AND THE CHANGE IN INCIDENCE OF RHF OVER TIME. A TOTAL OF 6,118 PATIENTS WHO RECEIVED A PRIMARY CONTINUOUS FLOW LVAD FROM 02JUNE2014 THROUGH 31MARCH2017 WERE RETROSPECTIVELY EVALUATED. AT 1 MONTH, 19% OF PATIENTS HAD MODERATE RHF. AT 3, 6, AND 12 MONTHS, APPROXIMATELY 10% OF PATIENTS HAD RHF. FOR PATIENTS ALIVE AND WITHOUT RHF BETWEEN 1 AND 3 MONTHS, THEIR SUBSEQUENT 6 AND 12 MONTH CUMULATIVE INCIDENCE OF MORTALITY WAS 2.3% AND 6.9%, RESPECTIVELY. HOWEVER, THE PRESENCE OF ANY DEGREE OF RHF AMONG SURVIVORS AT 3 MONTHS PORTENDED SIGNIFICANTLY WORSE OUTCOMES. THE 6 AND 12 MONTH CUMULATIVE INCIDENCE OF MORTALITY FOR THOSE WITH MILD RHF WAS 7.1% AND 16.7%, RESPECTIVELY, AND FOR THOSE WITH MODERATE RHF WAS 17.9% AND 28.1%, RESPECTIVELY, AND WAS SIGNIFICANTLY WORSE THAN THOSE WITH NO RHF (P < 0.0001). THERE WAS NO ASSOCIATION BETWEEN RHF AT 3 MONTHS AND SUBSEQUENT PUMP THROMBOSIS. IN CONTRAST, THERE WAS A SIGNIFICANTLY LOWER 12-MONTH CUMULATIVE INCIDENCE OF MANY ADVERSE EVENTS FOR THOSE WITH NO RHF COMPARED WITH THOSE WITH MILD AND MODERATE RHF. THE 12 MONTH CUMULATIVE INCIDENCE OF FIRST GASTROINTESTINAL (GI) BLEED WAS 14.8% IN THOSE WITH NO RHF VS 24.2% WITH MILD AND 23.6% WITH MODERATE RHF (P < 0.0001). SIMILARLY, THE CUMULATIVE INCIDENCE OF THE SECOND GI BLEED WAS LOWEST IN THE NO RHF GROUP. THE CUMULATIVE INCIDENCE OF STROKE WAS LOWEST IN THE NO RHF GROUP (7.4%), COMPARED WITH THOSE WITH MILD (9.5%) AND MODERATE RHF (11.0%) (P ¼ 0.0095). FINALLY, THE CUMULATIVE INCIDENCE OF VAD-RELATED INFECTIONS (DEFINED AS POSITIVE BLOOD CULTURES, LINE SEPSIS, AND MEDIASTINAL INFECTIONS), AND CARDIAC ARRHYTHMIAS WERE SIGNIFICANTLY LESS LIKELY AT 12 MONTHS IN THOSE WITH NO RHF COMPARED WITH THOSE WITH MILD OR MODERATE RHF.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2022-11213.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814271 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death