BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 6507426 · Received April 20, 2017

    Report

    Report Number
    3004066202-2017-00041
    Event Type
    Injury
    Date Received
    April 20, 2017
    Date of Event
    January 1, 2012
    Report Date
    October 17, 2017
    Manufacturer
    INVATEC TECHNOLOGY CENTER GMBH
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CIOPPA, A., ET AL. (2017). "COMBINED USE OF DIRECTIONAL ATHERECTOMY AND DRUG-COATED BALLOON FOR THE ENDOVASCULAR TREATMENT OF COMMON FEMORAL ARTERY DISEASE: IMMEDIATE AND ONE-YEAR OUTCOMES." EUROINTERVENTION 12(14): 1789-1794. DOI: 10.4244/EIJ-D-15-00187

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BETWEEN JANUARY 2012 AND JULY 2014, A STUDY WAS CARRIED OUT TO EVALUATE THE SAFETY, FEASIBILITY, AND ONE-YEAR EFFICACY OF THE ENDOVASCULAR TREATMENT OF CFA OBSTRUCTIONS WITH COMBINED USE OF DIRECTIONAL ATHERECTOMY (DA) AND A PACLITAXEL-COATED BALLOON (DCB). 30 PATIENTS UNDERWENT PTA OF A CALCIFIED LESION WITH THE USE OF DA AND DCB AT THE COMMON FEMORAL ARTERY. OF THIS COHORT, 25 PATIENTS WERE MALE (84%) AND MEDIAN AGE WAS 78 YEARS (RANGE 55 - 84). PATIENT MEDICAL HISTORY INCLUDED; HYPERTENSION, DYSLIPIDAEMIA, SMOKERS (PREVIOUS AND CURRENT), DIABETES (NON-INSULIN AND INSULIN DEPENDENT) AND RENAL FAILURE. TREATMENT INCLUDED THE COMBINED USE OF TURBOHAWK PLAQUE EXCISION SYSTEM AND A PROLONGED (3 MINUTES) DILATION USING IN.PACT ADMIRAL IN ALL CASES. DUE TO THE OCCURRENCE OF FLOW-LIMITING DISSECTION, PERSISTING AFTER PROLONGED DCB DILATATION (>5 MIN), BAIL-OUT STENTING WAS NECESSARY IN THREE CASES. A PROTEGE STENT WAS USED IN TWO OF THESE CASES. NO PROCEDURE-RELATED ADVERSE EVENTS OCCURRED. DURING FOLLOW-UP, RESTENOSIS OCCURRED IN TWO PATIENTS SIX MONTHS AFTER THE INDEX PROCEDURE AND IN ONE PATIENT AT 11 MONTHS AFTER THE INDEX PROCEDURE. IN-STENT RESTENOSIS OCCURRED IN ONE OF THE PATIENTS TREATED WITH BAIL-OUT STENTING. TWO TLRS WERE PERFORMED IN TWO PATIENTS SYMPTOMATIC FOR EARLY ONSET CLAUDICATION. FOR THE OTHER PATIENT, NO TLR WAS PERFORMED DUE TO THE LACK OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290534 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU INVATEC TECHNOLOGY CENTER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention