BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELITE

    MDR report key: 24264157 · Received February 4, 2026

    Report

    Report Number
    2124215-2026-06516
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729972099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DISSECTION AND THROMBUS OCCURRED. ANGIOGRAPHY REVEALED DOUBLE VASCULAR DISEASE, AND THE PATIENT WAS ADVISED TO HAVE PERCUTANEOUS CORONARY INTERVENTION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND RIGHT CORONARY ARTERY (RCA). THE DISTAL RCA INVOLVED A LARGE POSTERIOR LATERAL BRANCH (PLB). FOLLOWING PRE-DILATION WITH 1.50 X 12MM AND 2.00 X 12 MM BALLOONS, A 2.25 X 16 MM PROMUS ELITE DRUG ELUTING STENT WAS INSERTED INTO THE RCA. WHEN CHECKING THE VESSEL WITH DYE, THE PHYSICIAN FOUND BOTH THE POSTERIOR DESCENDING ARTERY (PDA) AND PLB WERE OCCLUDED WITH THROMBUS. THE STENT WAS WITHDRAWN AND A THROMBUS SUCTION CATHETER WAS INSERTED TO ASPIRATE THE THROMBUS. ANGIOGRAPHY SHOWED A LARGE DISSECTION AT THE BIFURCATION OF THE PDA AND PLB WHICH ALSO EXTENDED PROXIMALLY. A 2.25 X 30 MM NON-BOSTON SCIENTIFIC STENT WAS SUCCESSFULLY DEPLOYED FROM THE PLB TO DISTAL RCA COVERING THE ENTIRE SEGMENT WHERE THE THROMBUS AND DISSECTION WERE LOCATED. FINAL ANGIOGRAPHY SHOWED NO RESIDUAL STENOSIS OR DISSECTION AND TIMI III FLOW WAS ACHIEVED. THE PATIENT WAS STABLE AND SHIFTED TO THE CORONARY CARE UNIT. TWO DAYS LATER, THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326094 PROMUS ELITE STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 10672 0036469401 08714729972099

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| H