BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIANZA PRO 12

    MDR report key: 15158771 · Received August 3, 2022

    Report

    Report Number
    3004718255-2022-00269
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    June 7, 2022
    Report Date
    August 3, 2022
    Manufacturer
    ASAHI INTECC
    Product Code
    DQX
    UDI-DI
    04547327058162
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OPERATIONS PERFORMED: 1. U/S-GUIDED BILATERAL CFA ACCESS. 2. BILATERAL ILIAC ARTERY PRESSURE MEASUREMENTS. 3. BILATERAL COMMON ILIAC ARTERY (CIA) ANGIOPLASTY. 4. RIGHT CIA STENTING (7 X 59 VBX BES). 5. LEFT SFA RECANALIZATION. 6. LEFT SFA ANGIOPLASTY AND STENTING (5 X 120 ABBOTT SUPERA STENTS X 2; OVERLAPPING IN THE SFA). 7. ATTEMPTED RECANALIZATION OF RLE SFA (UNSUCCESSFUL). 8. BILATERAL PROGLIDE PERCLOSE ACCESS CLOSURE (1 DEVICE PER SIDE). IMPLANTED DEVICES: 1.  GORE VBX 7 MM X 59 MM BALLOON EXPANDABLE STENT IN THE RIGHT CIA. 2. ABBOTT SUPERA 5 MM X 120 MM SELF-EXPANDABLE STENTS X 2 IN THE LEFT SFA. DESCRIPTION: BILATERAL FEMORAL ACCESS PERFORMED TO ALLOW FOR AORTIC AND ILIAC PRESSURE MEASUREMENTS AND TREATMENT. PROCEEDED THEN WITH CONTRALATERAL 7F SHEATH ACCESS, STARTING WITH TREATING THE LEFT LEG FIRST. ANGIOPLASTY OF LEFT SFA WITH 5 MM X 200 MM BALLOON AND 6 X 80 MM BALLOONS BEFORE PLACING 5 MM X 120 MM SUPERA STENTS X 2 IN THE LEFT SFA FOR LEFT SFA OCCLUSION. MOVED TO RIGHT SIDE. SIMILAR ACCESS WITH 7F SHEATH FROM THE LEFT SIDE. ATTEMPTED TO CROSS THE R SFA CTO, UNSUCCESSFUL. COMPLICATIONS: TIP OF THE 0.014 WIRE (0.5 CM LONG) REMAINED IN THE PATIENT'S RIGHT SFA OCCLUSION WITHOUT CONCERN FOR EMBOLIZATION OR RESULTING ARTERIAL BLOCKAGE. OTHERWISE, NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411291 CONFIANZA PRO 12 GUIDE WIRE DQX ASAHI INTECC AGH143391 210831A111 04547327058162

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male