BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 6766931 · Received August 4, 2017

    Report

    Report Number
    3004066202-2017-00084
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    April 27, 2017
    Report Date
    July 7, 2017
    Manufacturer
    INVATEC SPA
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY TITLE: DEBULKING ATHERECTOMY IN THE PERIPHERAL ARTERIES: IS THERE A ROLE AND WHAT IS THE EVIDENCE? KONSTANTINOS KATSANOS, STAVROS SPILIOPOULOS, LAZAROS REPPAS, DIMITRIS KARNABATIDIS CARDIOVASC INTERVENT RADIOL (2017) 40:964-977 DOI: 10.1007/S00270-017-1649-6. DATE OF EVENT: DATE OF PUBLICATION OF THE ARTICLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE EXPLORES THE USE OF ATHERECTOMY IN PERIPHERAL ARTERY THERAPY. SEVERAL STUDIES ARE CALLED OUT IN THE ARTICLE, THE FIRST OF WHICH COMPARING PRIMARY BALLOON ANGIOPLASTY VERSUS SILVERHAWK DIRECTIONAL ATHERECTOMY WITH BALLOON ATHERECTOMY IN 58 PATIENTS SUFFERING FROM INTERMITTENT CLAUDICATION OR CRITICAL LIMB ISCHEMIA. DURING FOLLOW-UP, TLR, TVR AND MACRO EMBOLISATION WERE SEEN. THE SECOND STUDY INVESTIGATES DIRECTIONAL ATHERECTOMY WITH SILVERHAWK IN 601 PATIENTS. PROCEDURAL SUCCESS WAS ALMOST 98% WITH TARGET LESION REVASC NECESSARY IN APPROX 10% OF PATIENTS OVER THE FOLLOW UP PERIOD. ANOTHER STUDY LOOKED AT THE EFFECTIVENESS OF IF THE SILVERHAWK DEVICE IN A TOTAL OF 800 PATIENTS. DURING FOLLOW UP SAW 5% OF PATIENTS REQUIRING MAJOR UNPLANNED AMPUTATIONS, EMBOLISATION OCCURRED IN 4%, PERFORATION OCCURRED IN 5%, VESSEL OCCLUSION IN 2% AND STENTING REQUIRED IN 3% OF PATIENTS. A STUDY INVESTIGATING SILVERHAWK USE IN FEMOROPOPLITEAL LESIONS IN 84 PATIENTS SAW SIX DISTAL EMBOLISATION EVENTS OVER THE COURSE OF THE STUDY. A STUDY OF 30 PATIENTS WITH SEVERELY CALCIFIED SFA LESIONS THAT WERE TREATED UNDER FILTER PROTECTION USING THE TURBOHAWK SYSTEM FOLLOWED BY IN.PACT ADMIRAL DRUG-ELUTING BALLOONS. WHILE NO PROCEDURE-RELATED ADVERSE EVENTS TOOK PLACE, BAILOUT STENTING WAS NECESSARY IN 7% OF PATIENTS. FINALLY, A CONTROLLED STUDY SPONSORED BY MEDTRONIC COMPARED UPFRONT ATHERECTOMY WITH TURBOHAWK OR SILVERHAWK DEVICES FOLLOWED BY DRUG -ELUTING BALLOON ANGIOPLASTY VERSUS DRUG-ELUTING BALLOONS ALONE. DISSECTION OCCURRED IN 2% OF CASES AND BAILOUT STENTING WAS REQUIRED IN CERTAIN CASES. ONE YEAR RESTENOSIS ALSO OCCURRED IN SOME CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547463 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention