BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 7881525 · Received September 17, 2018

    Report

    Report Number
    9612164-2018-02415
    Event Type
    Death
    Date Received
    September 17, 2018
    Date of Event
    February 17, 2018
    Report Date
    September 17, 2018
    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

    FAILURE MODE AND BIMODAL RESTENOSIS OF DRUG-COATED BALLOON IN FEMOROPOPLITEAL INTERVENTION INTERNATIONAL JOURNAL OF CARDIOLOGY 259 ( 2018) 170¿177 HTTPS://DOI.ORG/10.1016/J.IJCARD.2018.02.040. AGE/DATE OF BIRTH: AVERAGE AGE. SEX: MAJORITY GENDER. DEATH DATE = LITERATURE ARTICLE PUBLISHED DATE. EVENT DATE = LITERATURE ARTICLE PUBLISHED DATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FAILURE MODE AND BIMODAL RESTENOSIS OF DRUG-COATED BALLOON IN FEMOROPOPLITEAL INTERVENTION INTERNATIONAL JOURNAL OF CARDIOLOGY 259 ( 2018) 170¿177 HTTPS://DOI.ORG/10.1016/J.IJCARD.2018.02.040 BACKGROUND: PATTERN OF DCB RESTENOSIS AND ASSOCIATED OUTCOMES IN FACING COMPLEX FEMOROPOPLITEAL LESIONS REMAIN UNCERTAIN. METHODS: DATA WERE RETROSPECTIVELY COLLECTED FROM DUAL CENTERS IN TAIWAN ON PATIENTS WHO UNDERWENT TREATMENT WITH DCBS FOR FEMOROPOPLITEAL LESIONS BETWEEN 2013 AND 2016. THE RESTENOSIS PATTERN WAS CATEGORIZED BY THE INDEX-TREATED LENGTH. CLINICAL OUTCOMES AND TIME TO DCB RESTENOSIS WERE RETROSPECTIVELY ANALYZED. COX PROPORTIONAL HAZARDS MODEL IDENTIFIED RESTENOSIS PREDICTORS. RESULTS: WE RECRUITED A TOTAL OF 164 PATIENTS (91 MEN; MEDIAN AGE 73 YEARS) INTO THE FINAL ANALYSIS. THE MEAN LESION LENGTH WAS 204.0 ± 109.2 MM. OF THEM, 45% TOTAL OCCLUSIONS, 28% SEVERE CALCIFICATION AND 15% IN-STENT RESTENOSIS WERE TREATED. FIFTY-FIVE PATIENTS HAVE DCB RESTENOSIS (28 FOCAL AND 27 DIFFUSE-OCCLUSIVE PATTERNS) OVER A 55-MONTH FOLLOW-UP. THE MEDIAN RESTENOSIS TIME EMERGED AS A BIMODAL PATTERN WITH A SIGNIFICANT DIFFERENCE BETWEEN THE DIFFUSE-OCCLUSIVE AND FOCAL RESTENOSIS GROUP (225 VS. 484 DAYS, P = 0.01). THE 1-YEAR PATENCY RATE AFTER REINTERVENTION FOR DCB RESTENOSIS ALSO WAS DIFFERENT BETWEEN BOTH RESTENOSIS GROUP (29% VS. 65%, P = 0.017). THE ANTICIPATED TIMING OF ESCAPE FOR DIFFUSE-OCCLUSIVE OR FOCAL RESTENOSIS WAS 687 AND 1068 DAYS, RESPECTIVELY. INDEPENDENT FACTORS WERE LESION LENGTH (P = 0.049) FOR DIFFUSE-OCCLUSIVE RESTENOSIS AND LUMEN GAIN OF THE POPLITEAL ARTERY FOR FOCAL RESTENOSIS (P = 0.034). CONCLUSIONS: THIS STUDY DEMONSTRATED TIME TO DCB FAILURE EMERGED AS A BIMODAL PATTERN OF DISTRIBUTION AND ASSOCIATIONS OF RESTENOSIS PATTERN TO SUBSEQUENT OUTCOMES AFTER THE REPEATED INTERVENTION. EXEMPTION FROM LATE CATCHUP RESTENOSIS REQUIRED 3-YEAR OBSERVATION INSTEAD OF THE 1-YEAR MARK FOR CONVENTIONAL TREATMENT. EVENT DESCRIPTION: IT WAS REPORTED PATIENTS WERE TREATED USING IN.PACT ADMIRAL DRUG ELUTING BALLOONS (DEB) TO TREAT FEMOROPOPLITEAL DISEASE. SEVERE CALCIFICATION AND CHRONIC TOTAL OCCLUSIONS WERE REPORTED IN SOME CASES. NO DEVICE MALFUNCTIONS WERE REPORTED. BAILOUT STENTING WITH BARE METAL STENTS WAS PERFORMED IN CASES WITH SUBOPTIMAL ANGIOGRAPHIC RESULTS OR FLOW LIMITING DISSECTIONS AFTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. OVER THE COURSE OF A 55 MONTH FOLLOW UP THERE WERE REPORTED CASES OF DEATH, ABOVE THE ANKLE AMPUTATION DUE TO WOUND INFECTION AND RESTENOSIS RESULTING IN THE REQUIREMENT FOR REPEATED ENDOVASCULAR THERAPY IN SOME CASES AND MEDICAL MANAGEMENT IN OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723728 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death