BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2223296 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03445
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: RECEIVED PRODUCT CONSISTED OF A PROMUS ELEMENT MONORAIL STENT DELIVERY SYSTEM (SDS) AND STENT. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT POSITIONED BETWEEN THE MARKERBANDS. THE BALLOON AND STENT APPEARED TO HAVE BEEN BENT/KINKED 6 MM FROM THE PROXIMAL EDGE OF THE STENT. MULTIPLE STENT STRUTS ON THE DISTAL END OF THE STENT WERE BENT DISTALLY. FURTHER INSPECTION PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO CROSS THE LESION AND THE TIP DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A NON BSC 2.5X20MM BALLOON. A 3.00X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LAD BUT WAS UNABLE TO CROSS THE LESION AND IT WAS NOTED THAT THE TIP WAS BENT. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE. THIS PRODUCT IS ONLY (B)(4) APPROVED BUT IT IS SIMILAR TO AN APPROVED 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 H7493911316300 14230856

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 2.50X20MM SILKY BALLOON CATHETER