BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 8373151 · Received February 27, 2019

    Report

    Report Number
    9612164-2019-00687
    Event Type
    Death
    Date Received
    February 27, 2019
    Date of Event
    August 15, 2018
    Report Date
    February 27, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE ARTICLE ACCEPTED JOURNAL ARTICLE TITLE: RISK FACTORS FOR RESTENOSIS AFTER DRUG-COATED BALLOON ANGIOPLASTY FOR COMPLEX FEMOROPOPLITEAL ARTERIAL OCCLUSIVE DISEASE ANN VASC SURG 2019; 55: 45¿54 HTTPS://DOI.ORG/10.1016/J.AVSG.2018.06.015 2018 ELSEVIER INC. ALL RIGHTS RESERVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS ARTICLE AIMS INVESTIGATE THE OUTCOMES OF PATIENT TREATED WITH DCBS AND TO IDENTIFY THE PREDICTORS OF RESTENOSIS. IT IS A RETROSPECTIVE ANALYSIS OF 120 PATIENTS (137 LIMBS) TREATED WITH DCBS FOR FEMOROPOPLITEAL LESIONS. THERE WERE 80 DE NOVO AND 57 IN-STENT RE STENOSIS LESIONS TREATED. CONTRALATERAL OR IPSILATERAL FEMORAL PUNCTURE WAS PERFORMED, DEPENDING ON THE TARGET LESION LOCATION AND CHARACTERISTICS. HEPARIN (5000 U) WAS ADMINISTERED AFTER VASCULAR ACCESS WAS OBTAINED TO ACHIEVE AN ACTIVATED CLOTTING TIME OF >250 SEC. A 7F SHEATH WAS USED FOR THE IPSILATERAL APPROACH, WHEREAS A CONTRALATERAL SHEATH (6 TO 8F) WAS APPLIED FOR THE CROSSOVER APPROACH. GENERALLY, A 0.018 OR 0.035-INCH GUIDEWIRE AND A SUPPORTING 4/5F MULTIPURPOSE CATHETER OR MICROCATHETER WERE USED TO CROSS THE OCCLUDED LESION. PRE-DILATATION WAS SYSTEMATICALLY PERFORMED BEFORE TREATMENT WITH DCB USING UNDERSIZED PLAIN BALLOON WITH DIAMETER 1 MM SMALLER THAN THE REFERENCE VESSEL DIAMETER. PRE-TREATMENT WITH ATHERECTOMY DEVICES SUCH AS SILVERHAWK OR TURBOHAWK WAS PERFORMED IN SELECTED CASES IN WHICH THE LESION WAS PARTICULARLY LONG OR HEAVILY CALCIFIED, OR WHEN THE LESION INVOLVED THE POPLITEAL ARTERY, BASED ON THE INTERVENTIONALIST¿S JUDGMENT. ALL PATIENTS WERE TREATED WITH IN.PACT ADMIRAL DCB SYSTEMS. DCB WAS ROUTINELY INFLATED FOR 3 MIN. IN CASES OF FLOW-LIMITING DISSECTION OR RESIDUAL STENOSIS OF >50% AFTER ADDITIONAL BALLOON DILATATION, PROVISIONAL NITINOL STENTS WERE IMPLANTED. AFTER DCB TREATMENT, A COMBINATION OF ANTIPLATELET AGENTS WERE ROUTINELY ADMINISTERED. TECHNICAL SUCCESS WAS ACHIEVED IN ALL PATIENTS. NO MAJOR COMPLICATIONS WERE OBSERVED. THERE WERE NO CASES OF MAJOR AMPUTATIONS OR RE INTERVENTION AT 30 DAYS AFTER THE INDEX PROCEDURE. THE 30-DAY MALE (MAJOR ADVERSE LIMB EVENT) WAS 0%. ELEVEN PATIENTS WERE LOST TO FOLLOW-UP AND 3 PATIENTS DIED DUE TO NONCARDIAC CAUSES. THE CLINICAL PRIMARY PATENCY FOR THE TOTAL STUDY POPULATION WAS 85.2% AT 1 YEAR AND 65.3% AT 2 YEARS. THE PATENCY OF THE TARGET LESION WAS ASSESSED IN 67 LIMBS (48.9%) BASED ON CHANGE IN RUTHERFORD CATEGORY AND ABI. THE TLR-FREE SURVIVAL WAS 93.0% AT 1 YEAR AND 87.1% AT 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167643 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death