BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11089889 · Received December 29, 2020

    Report

    Report Number
    2916596-2020-06346
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    April 1, 2019
    Report Date
    January 14, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED DRIVELINE INFECTIONS AS WELL AS A DIRECT CORRELATION TO THE DEVICES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE STUDY CONCLUDED THAT CAP TREATMENT IS A SAFE AND POTENT ALTERNATIVE TO SURGICAL INTERVENTIONS WHEN DEALING WITH DRIVELINE INFECTIONS. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE / PATIENT INFORMATION, ARE NOT AVAILABLE. THE HM 3 LVAS IFU LISTS DRIVELINE INFECTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. ADDITIONALLY, THE HM3 IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN 2019APR AND 2019SEP. AUTHOR: J. KREMER, ET AL. JOURNAL OF HEART AND LUNG TRANSPLANTATION, VOLUME: 39, ISSUE: 4, PAGES: S488. DOI: 10.1016/J.HEALUN.2020.01.058. CARDIAC SURGERY, UNIVERSITY HOSPITAL HEIDELBERG, HEIDELBERG, GERMANY. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE RESEARCH ABSTRACT ¿WOUND MANAGEMENT OF DRIVELINE INFECTIONS WITH COLD ATMOSPHERIC ARGON PLASMA - PROOF OF CONCEPT¿ IDENTIFYING THAT HM3 MAY BE RELATED TO DRIVELINE INFECTION (DLI). THIS STUDY EVALUATED THE SAFETY AND EFFICIENCY OF COLD ATMOSPHERIC PRESSURE ARGON PLASMA (CAP) ANTIMICROBIAL ACTIVITY IN THE TREATMENT OF DLI IN HM3 PATIENTS. BETWEEN 2019APR AND 2019SEPT 15 MALE PATIENTS WITH DLI WERE INCLUDED. FROM THESE 15 PATIENTS, 10 WERE IMPLANTED WITH HEARTMATE3 LVAD. BACTERIAL SPECIES WERE DETECTED BY STANDARD BACTERIAL SWABS. ANALYSIS OF 120 CAP TREATMENTS FOR DLI WAS PERFORMED IN ADDITION TO AN EXTENDED WOUND CARE. THE AVERAGE NUMBER OF CAP SESSIONS WAS 7.7 (1-17 SESSIONS/PATIENT). THERE WAS REDUCTION OF BACTERIAL LOAD IN TREATED WOUNDS IN 9 PATIENTS, REGARDLESS OF THE PATHOGEN. THERE WAS A SIGNIFICANT REDUCTION IN UTAH WOUND CLASSIFICATION BEFORE AND AFTER CAP TREATMENT (UTAH 2.80 VS. 1.18; P<0.001), AS WELL AS A SIGNIFICANT REDUCTION IN WOUND SIZE (16.08 VS. 1.90 CM3; P=0.047). THE MOST COMMON PATHOGEN WAS STAPHYLOCOCCUS AUREUS, IN 8 PATIENTS. NO ADVERSE EFFECTS OCCURRED, AND TREATMENT WAS WELL TOLERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556126 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R