BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADMIRAL XTREME

    MDR report key: 7039993 · Received November 16, 2017

    Report

    Report Number
    9612164-2017-01625
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    June 20, 2016
    Report Date
    November 16, 2017
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS LITERATURE ARTICLE PUBLISHED DATE ACOTEC DRUG-COATED BALLOON CATHETER: RANDOMIZED, MULTICENTER, CONTROLLED CLINICAL STUDY IN FEMOROPOPLITEAL ARTERIES: EVIDENCE FROM THE ACOART I TRIAL JACC: CARDIOVASCULAR INTERVENTIONS (2016) VOLUME:9, ISSUE:18, 1941-1949 HTTPS://DOI.ORG/10.1016/J.JCIN.2016.06.0.

    Description of Event or Problem · 1

    THIS STUDY WAS CONDUCTED TO INVESTIGATE THE EFFICACY AND SAFETY OF A NEW PACLITAXEL-COATED BALLOON CATHETER IN THE TREATMENT OF STENOTIC OR OCCLUDED FEMOROPOPLITEAL ARTERIES. TWO HUNDRED PATIENTS WITH PERIPHERAL ARTERIAL OCCLUSIVE DISEASE WERE PROSPECTIVELY RANDOMIZED TO TREATMENT WITH NEW PACLITAXEL-COATED OR STANDARD UNCOATED BALLOON CATHETERS. THE PRIMARY ENDPOINT WAS ANGIOGRAPHIC LATE LUMEN LOSS AT 6 MONTHS, MEASURED BY A BLINDED CORE LABORATORY. SECONDARY ANGIOGRAPHIC ENDPOINTS (6 MONTHS) AND SPECIFIC CLINICAL ENDPOINTS (1 YEAR) WERE BINARY RESTENOSIS, ANKLE-BRACHIAL INDEX, RUTHERFORD STAGE, CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (TLR), AND AMPUTATION. PATIENTS¿ MEAN AGE WAS 66 YEARS, 74% WERE MEN, 31% WERE SMOKERS, AND 55% HAD DIABETES. PATIENTS WERE TREATED WITH ADMIRAL XTREME PERIPHERAL BALLOON CATHETER. DURING THE PERIOD BETWEEN TREATMENT AND 6-MONTH FOLLOW-UP, 2 PATIENTS IN EACH TREATMENT GROUP (UNCOATED BALLOON AND DCB) DIED OF DISEASE; 1 PATIENT IN THE DCB GROUP DIED SHORTLY AFTER THE 6-MONTH ANGIOGRAPHIC CONTROL, BUT THE DEATH WAS REPORTED AT 6 MONTHS. TWO PATIENTS IN THE CONTROL GROUP WERE EXCLUDED BECAUSE OF TREATMENT WITH NONASSIGNED BALLOON, AND 1 PATIENT IN THE DCB GROUP WAS LOST TO FOLLOW-UP AFTER 6 MONTHS. A TOTAL OF 39.6% PATIENTS TREATED WITH UNCOATED BALLOON UNDERWENT TARGET LESION REVASCULARIZATION. IT WAS CONCLUDED THAT THE USE OF PACLITAXEL-COATED BALLOON CATHETERS MARKEDLY IMPROVED ANGIOGRAPHIC AND CLINICAL OUTCOMES OF INTERVENTIONS DESPITE ADVANCED DISEASE IN THE MAJORITY OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816156 ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT MEDTRONIC MEXICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention