BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3100501 · Received May 8, 2013

    Report

    Report Number
    2134265-2013-03343
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2013-03372, MDR ID # 2134265-2013-03373, MDR ID # 2134265-2013-03339. (B)(4). IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE, A VESSEL SPASM OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A 50 TO 70% IN-STENT RESTENOSIS OF PREVIOUSLY PLACED VERIFLEX BARE METAL STENT IN THE RIGHT CORONARY ARTERY (RCA). A KINETIX PTCA GUIDE WIRE WAS ADVANCED INTO THE DISTAL RCA AND A 2.75 X 32 MM PROMUS DRUG ELUTING STENT WAS PLACED. THEN, A 3.00 X 15 MM QUANTUM NONCOMPLIANT BALLOON CATHETER WAS USED FOR POST DILATATION OF THE LESION. A SPASM WAS THEN NOTED AT THE DISTAL VESSEL AND WAS TREATED WITH INTRACORONARY NITROGLYCERIN. ON THE SAME DAY THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201379 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention