BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA

    MDR report key: 15940888 · Received December 8, 2022

    Report

    Report Number
    2124215-2022-50044
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    October 1, 2015
    Report Date
    December 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT WAS APPROXIMATED BASED ON DATE OF STUDY IN THE ARTICLE. HAOCHENG MA, XUEMIN ZHANG, JING LI, QUINGLE LI, WEI LI, YANG JIAO, JINGJUN JIANG, CHANGSHUN HEM, ZHIBIN HE, WEIHAO LI, TAO ZHANG, AND XIAOMING ZHANG, P. R. CHINA. MID-TERM EFFICACY AND SAFETY OF DRUG-COATED BALLOON VERSUS NITINOL BARE METAL STENT FOR PRIMARY LESIONS IN FEMOROPOPLITEAL ARTERY DISEASE. ANN VASC SURG 2022; 81: 316-323.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT 2 STENTS FRACTURED RESULTING IN IN-STENT THROMBOSIS AND RESTENOSIS. THE STUDY COMPARED DRUG-COATED BALLOON (DCB) AND BARE METAL STENT (BMS) FOR PRIMARY LESIONS IN FEMOROPOPLITEAL ARTERY DISEASE IN CHINESE POPULATION AND TO MAKE SUBGROUP ANALYSIS BETWEEN THE GROUPS. LOCAL ANESTHESIA WAS USED IN ALL OPERATIONS. ARTERIAL ACCESS-SITE SELECTION WAS LEFT TO THE DISCRETION OF THE INVESTIGATOR. AFTER ARTERIAL PUNCTURE AND PLACEMENT OF A 5-7F INTRODUCER SHEATH, AN INITIAL DOSE 01 5000 IU HEPARIN WAS ADMINISTERED. INTRALUMINAL OR SUBINTIMAL LESION CROSSING WAS PERFORMED, USING STANDARD GUIDE WIRES AND CATHETERS. PRETREATMENT FOR TARGET LESIONS WAS THEN PERFORMED WITH BALLOON ANGIOPLASTY. ACCORDING TO THE DIAMETER OF NON LESION ARTERIES, BALLOONS WITH DIAMETERS RANGING FROM SMALL TO LARGE WERE USED FOR PREDILATION. DCB OR BMS WAS THEN USED AFTER PREDILATION DEPENDING ON THE DECISION OF CHIEF SURGEON. DCB WAS KEPT INFLATED FOR AT LEAST 180 SECOND AND BALLOON SIZE SELECTION WAS BASED ON A VISUAL ESTIMATE. TWO INNOVA STENTS IN THE BMS GROUP OCCURRED FRACTURE AT 2- AND 4-MONTHS POST OPERATION AND RESULTED IN IN-STENT THROMBOSIS AND RESTENOSIS. BOTH PATIENTS RECEIVED ENDOVASCULAR THROMBECTOMY AND COVERED STENT INSERTION AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585616 INNOVA STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention