BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2233248 · Received September 2, 2011

    Report

    Report Number
    2134265-2011-03698
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED THAT ONLY THE STENT OF THIS DEVICE WAS RETURNED FOR INVESTIGATION. THE STENT WAS DAMAGED ALONG IT'S LENGTH, AND MEASURED AT 45MM. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-03697. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DISLODGED. IN (B)(6) 2011, AFTER PRE-DILATION A 3.5X12MM PROMUS ELEMENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) AND POST DILATED TO 22 ATM'S WITH NO APPARENT COMPLICATIONS. THE RCA WAS MODERATELY CALCIFIED AND TORTUOUS. IN (B)(6) 2011, THE PATIENT STILL HAVING ANGINAL SYMPTOM WAS BROUGHT BACK TO TREAT THE RIGHT POSTERIOR DESCENDING ARTERY (PDA). THE PHYSICIAN ATTEMPTED TO ADVANCE A 2.75X24MM PROMUS ELEMENT STENT TO THE PDA BUT STRUGGLED TO PASS IT THROUGH THE PREVIOUSLY STENTED SECTION OF THE MID RCA AND THE 2.75X24MM PROMUS ELEMENT SNAGGED ON THE STENT STRUTS OF THE PREVIOUSLY PLACED STENT CAUSING IT TO COME OFF THE BALLOON. THE CONSULTANT MANAGED TO PULL IT BACK TO THE WRIST AREA WHERE A RADIOLOGIST SNARED IT OUT SUCCESSFULLY. THE PATIENT WAS BROUGHT BACK THE FOLLOWING WEEK AND IVUS REVEALED MAL-APPOSED STENT STRUTS ON THE FIRST STENT WHICH WAS RE-STENTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911324270 14284772

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 3.5X12MM PROMUS ELEMENT