BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 6192573 · Received December 21, 2016

    Report

    Report Number
    3004066202-2016-00319
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    July 14, 2016
    Report Date
    December 5, 2016
    Manufacturer
    INVATEC TECHNOLOGY CENTER GMBH
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT EVENT - MEAN AGE. DATE OF EVENT - DATE OF PUBLICATION JACC CARDIOVASCULAR INTERVENTIONS VOLUME 9, NO. 20, 2016 "LOCAL ULTRASOUND TO ENHANCE PACLITAXEL DELIVERY AFTER FEMORAL-POPLITEAL TR EATMENT IN CRITICAL LIMB ISCHEMIA" HTTP://DX.DOI.ORG/10.1016/J.JCIN.2016.07.019. 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

    A STUDY WAS CARRIED OUT TO EVALUATE THE SAFETY AND EFFICACY OF PERCUTANEOUS CATHETER-DELIVERED ULTRASOUND ENERGY TO IMPROVE LOCAL PA CLITAXEL DELIVERY EFFECTS IN PATIENTS WITH CRITICAL LIMB ISCHEMIA (CLI) TREATED FOR FEMORAL-POPLITEAL ARTERIAL DISEASE. PATIENTS WERE ELIGIBLE FOR ENROLMENT IF THEY HAD CLI (RUTHERFORD CLASS 4 TO 6) THE SINGLE-CENTER, SINGLE-BLIND, RANDOMIZED TRIAL INCLUDED 56 PATIENTS WITH CLI RANDOMLY ASSIGNED TO TREATMENT IN 2 GROUPS: 28 PATIENTS (THE CONTROL GROUP-) WERE TREATED WITH IN.PACT ADMIRAL DEB, AND 28 PATIENTS (THE STUDY GROUP) WERE TREATED WITH INTRAVASCULAR ULTRASOUND USING THE CARDIOPROLIFIC GENESIS SYSTEM . IN THE CONTROL GROUP, MEAN LESION LENGTH WAS 164 MM, AND 23 PATIENTS HAD CALCIFICATIONS. STENOSIS AND OCCLUSIONS WERE CROSSED USING A 0.035-INCH J-TIP AND OCCLUSION WITH A STRAIGHT-TIP HYDROPHILIC GUIDEWIRE SUPPORTED BY A DIAGNOSTIC CATHETER USING AN INTRALUMINAL APPROACH. AFTER CROSSING THE LESION, ANGIOPLASTY WAS PERFORMED USING A 0.035-INCH STANDARD PTA ADMIRAL BALLOON CATHETER. TO AVOID GEOGRAPHIC MISS, DEB LENGTH WAS CHOSEN TO EXCEED THE TARGET LESION LENGTH BY 10 MM AT THE PROXIMAL AND DISTAL EDGES. A MINIMUM BALLOON INFLATION TIME OF 180 S WAS ADOPTED. IN BOTH GROUPS, POST-PROCEDURAL MEDICAL THERAPY INCLUDED ASPIRIN 100 MG/DAY AND CLOPIDOGREL 75 MG/DAY FOR A MINIMUM OF 3MONTHS. AFTER 3 MONTHS, CLOPIDOGREL WAS DISCONTINUED; ASPIRIN THERAPY WAS CONTINUED FOR LIFE. RESULTS NO ADVERSE PROCEDURAL EVENTS WERE OBSERVED; ALL 56 PATIENTS TOLERATED THE PROCEDURE WELL. IN THE CONTROL GROUP , THREE DEATHS WERE REPORTED (2 MYOCARDIAL INFARCTIONS AND 1 SUDDEN DEATH). RESTENOSIS WAS OBSERVED. STENTING WAS NECESSARY DURING RE INTERVENTION IN 3 PATIENTS IN THE CONTROL GROUP TO MANAGE FLOW LIMITING DISSECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843684 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 75 YR Death