BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SION BLUE

    MDR report key: 15621394 · Received October 18, 2022

    Report

    Report Number
    3004718255-2022-00274
    Event Type
    Injury
    Date Received
    October 18, 2022
    Report Date
    October 17, 2022
    Manufacturer
    ASAHI INTECC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARDIOVASCULAR REVASCULARIZATION MEDICINE 40S (2022) S222-S224 TITLE: DISTAL CORONARY PERFORATION SEALING WITH COMBINED COIL AND FAT EMBOLIZATION. EXCERPT: AN 81-YEAR-OLD MAN WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION TO THE LEFT CIRCUMFLEX (LCX) ARTERY, PERIPHERAL VASCULAR DISEASEWITH PRIOR ILIAC ARTERY INTERVENTION, HYPERTENSION, DYSLIPIDEMIA, AND OBESITY PRESENTED WITH LEFT-SIDED CHEST PAIN WITH RADIATION TO THE LEFT ARM AND BACK. ELECTROCARDIOGRAM SHOWED SINUS RHYTHMWITH ST ELEVATIONS IN INFERIOR LEADS AND 2MMST-SEGMENT DEPRESSION IN THE ANTERIOR PRECORDIAL LEADS SUGGESTING INFERIOR/POSTERIOR ST-SEGMENT ELEVATION ACUTEMYOCARDIAL INFARCTION. EMERGENT CORONARY ANGIOGRAPHY, PERFORMED VIA RIGHT RADIAL ARTERY ACCESS, DEMONSTRATED A 90% STENOSIS IN THE DISTAL LCX AT THE LEVEL OF 2ND OBTUSE MARGINAL (OM) BIFURCATION THAT WAS CONSIDERED TO BE THE CULPRIT LESION (FIG. 1A; SUPPLEMENTAL VIDEO 1). IN ADDITION, THERE WAS AN 80% STENOSIS IN THE PROXIMAL AND A 70% IN-STENT RESTENOSIS IN THE MID-LCX. THE LCX WAS TORTUOUS AND HEAVILY CALCIFIED IN THE PROXIMAL TO MID SEGMENTS. THE LEFT ANTERIOR DESCENDING ARTERY AND RIGHT CORONARY ARTERY DID NOT HAVE SIGNIFICANT STENOSES. THE LEFT MAINWAS ENGAGEDWITH A 6-FRENCH EBU 3.75 GUIDE CATHETER FOLLOWED BY THE WIRING OF THE DISTAL LCX ANDOM2 USINGWORKHORSE GUIDEWIRES. BALLOON ANGIOPLASTYWAS PERFORMED USING A 3.0MM×12MMBALLOON. STENT DELIVERYWAS CHALLENGING DUE TO SIGNIFICANT TORTUOSITY AND VESSEL CALCIFICATION BUT WAS EVENTUALLY SUCCESSFUL THROUGH A 6-FRENCH GUIDE EXTENSION CATHETER. AFTER DEPLOYMENT OF A 3.0MM× 18.0MMDRUG-ELUTING STENT AT 24 ATM, THE OM2 DEVELOPED SEVERE OSTIAL STENOSIS. THE OM2 WAS REWIRED, AND KISSING BALLOON INFLATION WAS PERFORMED USING 2.5 × 12MMNON-COMPLIANT BALLOONS (FIG. 1B). TWO MORE STENTS WERE DELIVERED AND DEPLOYED IN THE MID AND PROXIMAL LCX AFTER DEEP INTUBATION WITH THE GUIDE EXTENSION CATHETER. THIS LIKELY CAUSED EXCESSIVE MOVEMENT OF SION BLUEWORKHORSE WIRE (ASAHI INTECC) RESULTING IN DISTAL VESSEL PERFORATION IN A BRANCH OF OM3 (FIG. 1C AND D; VIDEO 1; SUPPLEMENTAL VIDEO 2, SUPPLEMENTAL VIDEO 3). THE PATIENT WAS HEMODYNAMICALLY STABLE WITHOUT CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378001 SION BLUE GUIDE WIRE DQX ASAHI INTECC

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention