BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19635568 · Received June 28, 2024

    Report

    Report Number
    2916596-2024-03961
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    April 2, 2024
    Report Date
    August 6, 2024
    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. DETAILS ARE LISTED IN THE ATTACHED ABSTRACT. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE ¿ 02APR2024 SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. MICHEL CHEDID EL HELOU, ET AL. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY PUBLISHER. PUBLICATION DATE: 4/2/2024 VOLUME: 83 ISSUE: 13 PAGES: 301-301. DOI: 10.1016/S0735-1097(24)02291-5. CLEVELAND CLINIC, CLEVELAND, OH, USA THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE (PER SECTION 6.3.4 OF WI 90979616). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    B2: OUTCOME CORRECTED. E1: CUSTOMER SITE WAS CLEVELAND CLINIC AT 9500 EUCLID AVE, CLEVELAND, OH 44195. REPORTER CONTACT INFORMATION WAS NOT AVAILABLE. H6: IMPACT CODE CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 DEVICES AND THE REPORTED EVENTS 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 INSTRUCTIONS FOR USE (IFU) IS 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 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿RIGHT HEART FAILURE¿), STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. 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 TITLED ¿FACTORS ASSOCIATED WITH THE USE OF GUIDELINE DIRECTED MEDICAL THERAPY IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICE¿ IDENTIFYING HEARTMATE 3 (HM3) MAY BE RELATED WITH RIGHT HEART DYSFUNCTION. THIS STUDY AIMED TO CHARACTERIZE PATIENT FACTORS ASSOCIATED WITH USE OF GUIDELINE DIRECTED MEDICAL THERAPY (GDMT) IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) TO PROMOTE VENTRICULAR RECOVERY. THIS IS A RETROSPECTIVE STUDY THAT INCLUDED 270 PATIENTS (77% MALE, MEDIAN AGE 63). THE GDMT SCORE (0-8) FACTORED IN DOSES OF BETA-BLOCKER (BB), ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS AND ANGIOTENSIN II RECEPTOR BLOCKERS (ACEI/ARB), MINERALOCORTICOID RECEPTOR ANTAGONIST (MRA), ANGIOTENSIN RECEPTOR-NEPRILYSIN INHIBITOR AND SODIUM-GLUCOSE CO-TRANSPORTER-2 INHIBITOR (ARNI, SGLT2I), AND ISOSORBIDE DINITRATE-HYDRALAZINE (ISDN/HYD). MEDIAN GDMT SCORE WAS 3 ± 1.7, AND 155 PATIENTS (57.4%) HAD A SCORE OF 3 OR LOWER. PRESCRIPTION RATES WERE 50% FOR BB; 38.5% FOR ACEI/ARB; 14.8% FOR SGLT2I; 36.3% FOR ARNI; 47% FOR MRA; AND 19.6% FOR ISDN/HYD. IN UNIVARIABLE LOGISTIC REGRESSION, HIGHER AGE AND RIGHT VENTRICULAR (RV) DYSFUNCTION WERE ASSOCIATED WITH A GDMT SCORE BELOW THE MEDIAN, WITH AGE REMAINING A SIGNIFICANT PREDICTOR AFTER ADJUSTMENT. IN MULTIVARIABLE ANALYSIS FOR INDIVIDUAL DRUGS, RV DYSFUNCTION WAS LINKED TO NON-USE OF BETA BLOCKERS, BUT NO SIGNIFICANT PREDICTORS WERE IDENTIFIED FOR OTHER THERAPIES. WHILE RV DYSFUNCTION LIMITS BB USE AND ADVANCING AGE IS ASSOCIATED WITH LOWER USE OF GDMT IN HM3 PATIENTS, PATIENT FACTORS DO NOT ADEQUATELY EXPLAIN LOW PRESCRIBING RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184501 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R