BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21305131 · Received February 4, 2025

    Report

    Report Number
    2916596-2025-00648
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    January 1, 2021
    Report Date
    February 4, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT WAS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN 2010- 2021. SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. SECTION E1: REPORTER CONTACT INFORMATION WAS NOT AVAILABLE. AUTHOR CITATION: BHADRA, O., ET AL (2024). OUTCOME OF LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION WITH CONCOMITANT AORTIC VALVE PROCEDURE. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 43(4), S288. HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.02.1235. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, INCLUDING STROKE AND RIGHT HEART FAILURE. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INTERNATIONAL NORMALIZED RATIO (INR) VALUES. THIS SECTION ALSO STATES THAT SUDDEN RIGHT VENTRICULAR FAILURE MAY DEVELOP DURING OR SHORTLY AFTER PUMP IMPLANTATION AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. 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 " OUTCOME OF LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION WITH CONCOMITANT AORTIC VALVE PROCEDURE" THAT THE HEARTMATE 3 MAY BE RELATED TO DEATH, CARDIOGENIC SHOCK, IN HOSPITAL STROKES, AND RIGHT HEART FAILURE. SOME PATIENTS WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) REQUIRE SURGICAL AORTIC VALVE PROCEDURES (AVP) DUE TO MODERATE OR SEVERE AORTIC VALVE REGURGITATION (AR) TO ENSURE SUFFICIENT LVAD FUNCTION. IT IS UNCERTAIN HOW CONCOMITANT AVP DURING LVAD IMPLANTATION IMPACTS OUTCOMES. SO, THE STUDY WAS TO EVALUATE THE CLINICAL RESULTS OF PATIENTS RECEIVING AN LVAD CONCOMITANT WITH AVP IN COMPARISON WITH ISOLATED LVAD IMPLANTATION. 183 PATIENTS WITH ADVANCED HEART FAILURE UNDERWENT LVAD IMPLANTATION BETWEEN 2010-2021. OF THESE, 15 PATIENTS (GROUP 1) UNDERWENT LVAD IMPLANTATION WITH CONCOMITANT AVP AND WERE COMPARED WITH 140 PATIENTS (GROUP 2) WITH ISOLATED LVAD IMPLANTATION. DATA WERE RETROSPECTIVELY ANALYZED. THE RESULTS SHOWED BOTH GROUPS HAD PATIENTS THAT WENT INTO ACUTE CARDIOGENIC SHOCK (INTERMACS PROFILE 1 + 2, GROUP 1 VS. GROUP 2: 41 VS. 33%, P=0.8). INDICATION FOR AVP WAS MODERATE OR SEVERE AR. 13 PATIENTS UNDERWENT AORTIC VALVE REPLACEMENT AND 2 BENTALL PROCEDURE. IMPLANTED PERMANENT VAD DEVICES WERE HVAD AND HEART MATE 3 (HM3) (GROUP 1: HVAD: 93.4%, HM3: 6.6%; GROUP 2: HVAD: 79.9%, HM3: 21.1%, P=0.2). PROCEDURE AND BYPASS TIME WERE SIGNIFICANTLY LONGER IN GROUP 1. IN-HOSPITAL STROKE (0 VS. 1.6%, P=0.8) AND RETHORACOTOMY RATES (0 VS. 0%, P=1.0) WERE LOW IN BOTH GROUPS. RATES OF CONCOMITANT TEMPORARY RIGHT VENTRICULAR ASSIST DEVICE (RVAD) IMPLANTATION (13.3 VS. 22.0%, P=0.7) AND CONSECUTIVE RIGHT HEART FAILURE IN THE FIRST 3 MONTHS (5.5 VS. 5.1%, P=1.0) SHOWED NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS. GROUP 1 PATIENTS HAD A COMPARABLE 30-DAY RATE OF MORTALITY (6.6 VS. 13.6%, P=0.6). IN CONCLUSION, LVAD IMPLANTATION WITH CONCOMITANT AVP IS SAFE AND SHOWS EQUIVALENT RESULTS COMPARED TO ISOLATED LVAD IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61086 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention