BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 6799778 · Received August 17, 2017

    Report

    Report Number
    9612164-2017-01120
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    March 25, 2017
    Report Date
    July 18, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL OUTCOMES OF REPETITION OF DRUG-COATED BALLOON FOR FEMOROPOPLITEAL RESTENOSIS AFTER DRUG-COATED BALLOON TREATMENT SHIH-JUNG JANG, HSIN-HUA CHOU, JYH-MING JIMMY JUANG CIRCULATION JOURNAL 2017 VOL.81 DOI: 10.1253/CIRCJ.CJ-17-0025. 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 POPULATION FOR THIS STUDY (102 PATIENTS) WAS DERIVED FROM THE (B)(6) REGISTRY AN ONGOING, REGISTRY OF PATIENTS WHO UNDERWENT EVT FOR LOWER LIMB ISCHEMIA. PATIENTS WITH FP RESTENOSES AFTER THE FIRST DCB PROCEDURE WERE ENTERED INTO THE OUTCOME ANALYSIS TO COMPARE THE EFFICACY BETWEEN REPETITION (GROUP A) AND NO REPETITION (GROUP B) DCB FOR THOSE LESIONS. DURING THE STUDY PERIOD, 47 PATIENTS HAD DCB RESTENOSIS. AFTER EXCLUDING 7 ASYMPTOMATIC PATIENTS AND 3 WHO UNDERWENT VIABAHN STENT GRAFT TREATMENT, THE REMAINING 37 PATIENTS WERE DIVIDED INTO 2 GROUPS BASED ON WHETHER DCB WAS REPEATED. NO SIGNIFICANT DIFFERENCES WERE FOUND REGARDING AGE, SEX, UNDERLYING COMORBIDITIES, AND CLINICAL PRESENTATION. THE RATIOS OF SEVERE CALCIFICATION, VESSEL OCCLUSION, LESION LOCATION, AND DISTAL RUNOFF WERE SIMILAR BETWEEN GROUPS. 3 TYPES OF DCB WERE USED IN GROUP A (COMPRISING OF 16 PATIENTS ¿ 43 LESIONS WITH 44% OF THESE BEING ISR LESIONS AND THE REMAINING 56% NON-ISR LESIONS), INCLUDING 14 IN.PACT ADMIRAL DEVICES. THE MAIN EVENTS WERE DOCUMENTED AT DISCHARGE AND FOLLOW-UP VISITS. THE PROCEDURAL AND FOLLOW-UP OUTCOMES ARE OUTLINED BELOW: OF THE 16 PATIENTS TREATED IN GROUP A; 44% OF THESE REQUIRED ADDITIONAL STENTING. THE AVERAGE NUMBER OF DAYS WITHIN THIS GROUP FOR RE-EVT WAS 410DAYS. THERE WERE NO DEATHS RECORDED IN THIS GROUP AND 2 PLANNED MINOR AMPUTATIONS. OF THE 21 PATIENTS TREATED IN GROUP B; 52% OF THESE REQUIRED ADDITIONAL STENTING. THE AVERAGE NUMBER OF DAYS WITHIN THIS GROUP FOR RE-EVT WAS 400. THERE WERE NO DEATHS RECORDED IN THIS GROUP AND 3 PLANNED MINOR AMPUTATIONS. IN CONCLUSION, OF THE 37 PATIENTS UNDERGOING RE-EVT, THE 2-YEAR PRIMARY PATENCY WAS 58. THIS STUDY HAS ALSO DEMONSTRATED THAT THE RESULTS OF POBA OR BNS FOR DCB RESTENOSIS WERE DISCOURAGING FOR EITHER ISR OR NON-ISR LESIONS. THE RATES OF FREEDOM FROM BINARY RESTENOSIS AND CD-TLR AT 1 YEAR WERE 14% AND 38%, RESPECTIVELY. IN CONTRAST, THIS STUDY HAS DEMONSTRATED THE SUPERIORITY OF REPEATED DCB IN MANAGING DCB RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581441 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention