BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21435333 · Received February 21, 2025

    Report

    Report Number
    2916596-2025-00960
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    September 1, 2024
    Report Date
    March 11, 2025
    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

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE (R.E.A., D.S., E.K., J.A., G.R.J., C.I., J.M.G., V.N.R., M.J.G., J.M.H., J.R.W., B.A.H., R.J.T., A.P.C.) AND DEPARTMENT OF CARDIOTHORACIC SURGERY (A.K.), MEDICAL UNIVERSITY OF SOUTH CAROLINA, CHARLESTON. PRISMA HEALTH, COLUMBIA, SC (M.R.). DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE, UNIVERSITY OF LOUISVILLE, KY (S.F.). AKDOGAN, R. E., SILVERMAN, D., ROFAEL, M., FU, S., KOZAILY, E., ATKINS, J., CARNICELLI, A. P. (2024). ACUTE HEMODYNAMIC EFFECTS OF PACING IN PATIENTS SUPPORTED BY A HEARTMATE 3 DURABLE LEFT VENTRICULAR ASSIST DEVICE. CIRCULATION.HEART FAILURE, 17(9), E012080. DOI: HTTP://DX.DOI.ORG/10.1161/CIRCHEARTFAILURE.124.012080. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE EVENT DATE WAS ESTIMATED. DATE OF EVENT HAS BEEN ENTERED AS THE DATE OF PUBLICATION (SEP2024) SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED RIGHT VENTRICULAR DYSFUNCTION AND TRICUSPID REGURGITATION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, 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. SECTION 6, "PATIENT CARE AND MANAGEMENT" (UNDER "RIGHT HEART FAILURE"), DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING INOTROPES AND RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. SECTION 6 (UNDER CAUTION!) STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP." 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 "ACUTE HEMODYNAMIC EFFECTS OF PACING IN PATIENTS SUPPORTED BY A HEARTMATE 3 DURABLE LEFT VENTRICULAR ASSIST DEVICE" THAT THE HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH TRICUSPID REGURGITATION AND HEMODYNAMIC INSTABILITY. 26 PATIENTS WERE ENROLLED IN THE STUDY (19% FEMALE, 81% MALE; MEAN±SD; AGE, 60±10 YEARS). 7 WERE ENROLLED WITHIN 1 WEEK OF LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION, THE OTHERS RANGED FROM 4 WEEKS TO 3 YEARS POST-OPERATIVELY. 9 PATIENTS HAD RIGHT VENTRICULAR (RV) ONLY PACING, 7 HAD RIGHT ATRIAL (RA)/RV SEQUENTIAL PACING, AND 10 HAD BIVENTRICULAR PACING. AT BASELINE, MEAN TRICUSPID ANNULAR PLANE SYSTOLIC EXCURSION WAS 1.2±0.4 CM, MEAN RIGHT ATRIAL PRESSURE (RAP) WAS 8.4±5.8 MM HG, MEAN PULMONARY ARTERY PULSATILITY INDEX (PAPI) WAS 4.4±4.2, AND MEAN RIGHT VENTRICULAR STROKE WORK INDEX (RVSWI) WAS 5.3±3 G.M/M2 PER BEAT. TWO PATIENTS HAD SEVERE TRICUSPID REGURGITATION AT BASELINE. AMONG ALL THE PATIENTS RAP, CARDIAC INDEX (CI), RA/PULMONARY ARTERY WEDGE PRESSURE (PAWP), RVSWI, AND PAPI DID NOT SIGNIFICANTLY CHANGE WITH INCREASED PACING RATES; HOWEVER, PAWP SIGNIFICANTLY INCREASED. THESE FINDINGS WERE NOT AFFECTED BY PACING TYPE, TIME SINCE LVAD IMPLANT, OR INPATIENT/OUTPATIENT STATUS. AMONG PATIENTS NOT PACED AT BASELINE (N=20), THERE WAS NO SIGNIFICANT CHANGE IN PAWP, CI, RAP, OR RA/ PAWP FROM BASELINE TO PACING 5 BPM ABOVE BASELINE, THOUGH RVSWI SIGNIFICANTLY DECREASED (6.9±2.0 VER SUS 5.7±2.4 G.M/M2 PER BEAT; P=0.003). NINE OF THESE PATIENTS HAD RV-ONLY PACING, IN WHOM RAP SIGNIFICANTLY INCREASED (8.7±5.0 VERSUS 12.0±6.0 MM HG, P=0.01) WHILE RVSWI AND PAPI DECREASED (5.7±1.8 VERSUS 4.1±2.6 G.M/M2 PER BEAT; P=0.01; 4.7±5 VERSUS 2.0±1; P=0.01). FOR THOSE PACED AT BASELINE (N=6), INITIAL HEART RATE RANGED BETWEEN 55 AND 110 BPM (MEAN, 86 BPM). THERE WAS NO SIGNIFICANT CHANGE IN RAP, PAWP, CI, PULMONARY ARTERY SATURATION, OR RA/PAWP RATIO BETWEEN BASELINE AND THE FIRST 20 BPM PACING INCREMENT, THOUGH RVSWI AND PAPI SIGNIFICANTLY DECREASED WITH PACING (5.2±2.4 VERSUS 4.5±2.0 G.M/M2 PER BEAT; P=0.001; 4.4±5 VERSUS 2.6±1.8; P=0.001). LVAD SPEEDS WERE NOT CHANGED DURING THIS STUDY. PHYSIOLOGICALLY, THE LACK OF BENEFIT WITH PACING COULD RELATE TO VENTRICULAR DESYNCHRONY, LOSS OF PERICARDIAL INTEGRITY DURING LVAD IMPLANT, THE IMPACT OF MECHANICAL LEFT VENTRICULAR UNLOADING ON RV FUNCTION, OR PACING-MEDIATED WORSENING OF LEFT VENTRICULAR HEMODYNAMICS. IN THIS STUDY PACING IN PATIENTS WITH LVAD DID NOT IMPROVE CI BUT WORSENED RV FUNCTION AND INCREASED PAWP CONSISTENTLY ACROSS ALL PACING TYPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471794 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other