BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14689621 · Received June 14, 2022

    Report

    Report Number
    2916596-2022-11396
    Event Type
    Death
    Date Received
    June 14, 2022
    Date of Event
    April 1, 2022
    Report Date
    August 3, 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
    003

    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 (APRIL 2022) SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE (HM) 3 DEVICES AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT TITLED ¿CHARACTERIZING OUTFLOW GRAFT NARROWING OVER TIME¿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¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS INCLUDING STROKE, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, OUTLINES CONSIDERATIONS FOR PUMP PLACEMENT AND PROVIDES INSTRUCTIONS REGARDING THE PREPARATION, INSTALLATION, AND ORIENTATION OF THE SEALED OUTFLOW GRAFT. SECTION 5, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP," INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. SECTION 5 OF THE IFU, UNDER "PREIMPLANT PROCEDURES" AND "IMPLANT PROCEDURES" CAUTIONS THE USER: "THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT OR BODY STRUCTURE" AND "STRETCH THE SEALED OUTFLOW GRAFT COMPLETELY PRIOR TO MEASURING AND CUTTING THE GRAFT TO THE APPROPRIATE LENGTH." SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "CHARACTERIZING OUTFLOW GRAFT NARROWING OVER TIME" IDENTIFYING THAT CASES OF PUMP DYSFUNCTION DUE TO OUTFLOW GRAFT (OG) ANASTOMOSIS OBSTRUCTION RELATED TO SEROUS FLUID ACCUMULATION HAVE BEEN REPORTED BUT THE RATE OF OCCLUSION AND ACTUAL FREQUENCY OF ASYMPTOMATIC OG DIMINUTION IS NOT KNOWN. THIS WAS A MULTICENTER RETROSPECTIVE ANALYSIS OF PATIENTS ON HEARTMATE II (HMII) OR HEARTMATE 3 (HM3) SUPPORT SURVIVING AT LEAST 180 DAYS WITH AT LEAST ONE CHEST COMPUTED TOMOGRAPHY (CT) SCAN AT 6 MONTHS, 1, 2, AND/OR 3 YEARS POSTOPERATIVE. PATIENTS WITH OG OBSTRUCTION DUE TO TORSION WERE EXCLUDED. THE OUTFLOW GRAFT (OG) DIAMETER WAS MEASURED AT ITS NARROWEST REGION; REGION WAS CATEGORIZED AS EXTERNAL OUTFLOW GRAFT (EOG), MID-GRAFT, OR WITHIN 2 CM OF THE AORTIC ANASTOMOSIS. MIXED MODELS WITH REPEATED MEASURE LINEAR REGRESSION WAS USED TO ASSESS OG DIAMETER CHANGE OVER TIME, WITH 14 MM AS REFERENCE. USING THE NARROWEST MEASURE, OG DIAMETER WAS MODELLED FOR FREEDOM FROM DEATH, ADMISSION FOR HF AND LOW FLOW ALARMS WITH HAZARD RATIO [95% CI PRESENTED]. OF 71 PATIENTS INCLUDED HEREIN, 25% AND 75% WERE ON HMII AND HM3 SUPPORT FOR A MEDIAN [25TH, 75TH] 1230 [703,1592] DAYS. AT FOLLOW-UP, SMALL (1-3 MM, TABLE), BUT STATISTICALLY SIGNIFICANT REDUCTIONS IN OG DIAMETER WERE NOTED (FIGURE). THE MEDIAN OG NARROWING WAS 7% [0%, 20%]. TIME FROM DEVICE IMPLANT WAS THE MOST SIGNIFICANT CONTRIBUTING FACTOR (P<0.001) WHILE WRAPPING OF THE OUTFLOW WAS NONSIGNIFICANTLY CORRELATED WITH OG NARROWING (P=0.071). DEVICE MODEL WAS NOT CORRELATIVE (P=0.16). OG DIAMETER WAS NOT CORRELATED WITH SURVIVAL (HR 1.04 [0.81-1.3]), STROKE (HR 0.94 [0.78-1.1]) OR ADMISSIONS FOR HEART FAILURE (HR 1.06 [0.88-1.3]), OR VAD ALARMS (HR 0.93 [0.79-1.1]). MINOR NARROWING OF THE OG WAS NOTED OVER TIME, IRRESPECTIVE OF LEFT VENTRICULAR ASSIST DEVICE (LVAD) MODEL. THE OBSERVED DEGREES OF NON-TWIST RELATED-OG NARROWING HEREIN DID NOT LEAD TO INCREASE MORTALITY OR EVENTS. OG WRAPPING MAY BE ASSOCIATED WITH OG NARROWING OVER TIME. LARGER SAMPLE ANALYSES AIM TO DEFINE DEGREES OF NARROWING THAT ELICIT DEVICE DYSFUNCTION. RELATED MANUFACTURER'S REPORT CAPTURING MALFUNCTION: 2916596-2022-11398.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658104 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R