BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 15575461 · Received October 11, 2022

    Report

    Report Number
    2916596-2022-14421
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    November 1, 2014
    Report Date
    November 17, 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

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION A1-A6, D4: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBERS ARE DOCUMENTED AS UNKNOWN. SECTION B3: THE EVENT DATE HAS BEEN ESTIMATED AS THE DATA WAS COLLECTED BETWEEN NOVEMBER 2014 AND NOVEMBER 2021. ARTICLE TITLE: LESS IS BETTER? COMPARING EFFECTS OF MEDIAN STERNOTOMY AND THORACOTOMY SURGICAL APPROACHES FOR LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION ON POSTOPERATIVE OUTCOMES AND VALVULOPATHY. JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY ELSEVIER INC. (2022). SECTION E: (B)(6). 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 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE STUDY COMPARED OUTCOMES AFTER LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION PERFORMED VIA MEDIAN STERNOTOMY OR LATERAL THORACOTOMY. A TOTAL OF 222 ADULT PATIENTS IMPLANTED WITH A HEARTMATE 3 LVAD BETWEEN NOVEMBER OF 2014 AND NOVEMBER OF 2021 WERE ANALYZED. PATIENTS EXPERIENCED EARLY RIGHT VENTRICULAR FAILURE (RATES OF 24.4% AND 53.7% FOR THE LATERAL AND MEDIAN GROUPS), FOLLOW-UP TRICUSPID REGURGITATION (17.6% IN THE LATERAL GROUP), AND READMISSIONS FOR VOLUME OVERLOAD. SPECIFIC DEVICE SERIAL NUMBERS WERE NOT PROVIDED, AND NO PRODUCT WAS AVAILABLE FOR EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING RIGHT HEART FAILURE. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS RIGHT HEART FAILURE AS A POTENTIAL RISK/ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION (UNDER ¿RIGHT HEART FAILURE¿) ALSO OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. SECTION 5 ¿SURGICAL PROCEDURES¿ WARNS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT TIME OF DEVICE IMPLANT. THIS SECTION OF THE IFU ALSO WARNS THAT PATIENTS WITH MITRAL OR AORTIC MECHANICAL VALVES MAY BE AT ADDED RISK OF ACCUMULATING THROMBI ON THE VALVE WHEN SUPPORTED WITH LEFT VENTRICULAR ASSIST DEVICES. THE APPLICABLE SERIAL/LOT NUMBERS OF THE HEARTMATE 3 LVAD'S (LEFT VENTRICULAR ASSIST DEVICES) ASSOCIATED WITH THE REPORTED EVENTS WERE NOT PROVIDED AND WERE UNABLE TO BE IDENTIFIED. 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 ¿MICROEMBOLIC SIGNAL MONITORING IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES HEARTMATE 3 AND HEARTWARE¿ASSOCIATION WITH ANTITHROMBOTIC TREATMENT AND CEREBROVASCULAR EVENTS¿ IDENTIFYING THAT THE OBJECTIVE WAS TO COMPARE OUTCOMES AFTER LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION PERFORMED VIA MEDIAN STERNOTOMY OR LATERAL THORACOTOMY.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿MICROEMBOLIC SIGNAL MONITORING IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES HEARTMATE 3 AND HEARTWARE¿ASSOCIATION WITH ANTITHROMBOTIC TREATMENT AND CEREBROVASCULAR EVENTS¿ THAT SECONDARY OUTCOMES OF THE STUDY INCLUDED READMISSIONS TO THE HOSPITAL AND SIGNIFICANT VALVULAR REGURGITATION. PATIENTS IN THE STUDY ALSO EXPERIENCED RIGHT VENTRICULAR FAILURE, TRICUSPID VALVE REGURGITATION, AND VOLUME OVERLOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411853 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O| L