BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 9304794 · Received November 11, 2019

    Report

    Report Number
    9612164-2019-04706
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    May 25, 2012
    Report Date
    November 11, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE: COMBINED TREATMENT OF HEAVY CALCIFIED FEMORO-POPLITEAL LESIONS USING DIRECTIONAL ATHERECTOMY AND A PACLITAXEL COATED BALLOON: ONE-YEAR SINGLE CENTRE CLINICAL RESULTS 1553-8389/$ ¿ SEE FRONT MATTER © 2012 ELSEVIER INC. ALL RIGHTS RESERVED. DOI:10.1016/J.CARREV.2012.04.007 220 A. CIOPPA ET AL. / CARDIOVASCULAR REVASCULARIZATION MEDICINE 13 (2012) 219¿223. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BACKGROUND: THE USE OF DIRECTIONAL ATHERECTOMY (DA) FOR THE TREATMENT OF CALCIFIED FEMORO-POPLITEAL LESIONS SEEMS TO IMPROVE THE ACUTE PROCEDURAL SUCCESS, HOWEVER WITHOUT REDUCING THE LONG TERM RESTENOSIS RATE. DRUG COATED BALLOONS (DCB) REDUCED RESTENOSIS RATE IN NON HEAVY CALCIFIED LESIONS. AIM OF THIS STUDY WAS TO DEMONSTRATE SAFETY AND EFFICACY OF A COMBINED ENDOVASCULAR APPROACH USING DA AND DCB FOR THE TREATMENT OF HEAVY CALCIFIED LESIONS OF THE FEMORO-POPLITEAL TRACT. METHODS: FROM JANUARY 2010 TO NOVEMBER 2010, 240 PATIENTS UNDERWENT PTA OF THE FEMORO-POPLITEAL TRACT IN OUR INSTITUTION. WITHIN THIS COHORT A TOTAL OF 30 PATIENTS HAD LIFE LIMITING CLAUDICATION (LLC) (N= 18) AND 12 A CRITICAL LIMB ISCHEMIA (CLI) WITH BASELINE RUTHERFORD CLASS 4.2± 1.2 UNDERWENT PTA OF HEAVY CALCIFIED LESIONS WITH INTRAVASCULAR ULTRASOUND GUIDED DA AND DCB. ALL PROCEDURES HAVE BEEN PERFORMED USING A DISTAL PROTECTION DEVICE. STENT IMPLANTATION WAS ALLOWED ONLY IN CASE OF FLOW LIMITING DISSECTIONS OR SUBOPTIMAL RESULT (RESIDUAL STENOSIS>50%) BY VISUAL ESTIMATION. AFTER THE INTERVENTION PATIENTS WERE FOLLOWED UP TO 12 MONTHS. RESULTS: PROCEDURAL AND CLINICAL SUCCESS, WAS ACHIEVED IN ALL CASES. BAIL-OUT STENTING WAS NECESSARY IN ONLY TWO (6.5%). TWO MINOR, FOOT FINGER OR FOREFOOT AMPUTATIONS, WERE PERFORMED TO REACH COMPLETE WOUND HEALING AND/OR PRESERVE DEAMBULATION. DUPLEX CONTROL WAS PERFORMED IN ALL THE CASES (N= 30). IN THREE CASES DUPLEX SCAN SHOWED A SIGNIFICANT TARGET LESION RESTENOSIS REQUIRING A REINTERVENTION (TLR= 10%) LEADING A TOTAL ONE-YEAR SECONDARY PATENCY RATE OF 100%. ALL THE THREE RESTENOSED PATIENTS WERE INSULIN DEPENDENT DIABETICS AND NONE OF THEM WERE STENTED DURING THE PROCEDURE. CONCLUSION: THE DATA SUGGEST THAT COMBINED USE OF DA AND DCB MAY REPRESENT A POTENTIAL ALTERNATIVE STRATEGY FOR THE TREATMENT OF FEM ORO-POPLITEAL SEVERELY CALCIFIED LESIONS. THESE VERY PROMISING DATA AND THE CONSIDERED HYPOTHESIS HAVE TO BE CONFIRMED IN A MULTICENTRE RANDOMISED TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100330 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 Required Intervention