BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3100265 · Received May 8, 2013

    Report

    Report Number
    2134265-2013-02999
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE HYPOTUBE WAS SEVERELY KINKED IN TWO LOCATIONS. THE FIRST KINK WAS LOCATED AT 27CM DISTAL TO THE STRAIN RELIEF AND THE SECOND KINK WAS LOCATED AT 79.2CM DISTAL TO THE STRAIN RELIEF. AN EXAMINATION OF THE CRIMPED STENT, BALLOON AND TIP FOUND NO ISSUES WITH THEIR PROFILES. NO DAMAGE WAS NOTED WITH THE CRIMPED STENT. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. AFTER PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED WITH A 2.5MM BALLOON CATHETER, THE 3.00 X 12 MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. THERE WAS DIFFICULTY CROSSING THE LESION AS THE GUIDE CATHETER WAS NOT ENGAGED PROPERLY. ANOTHER GUIDEWIRE WAS USED AS A SUPPORT, AND ADVANCED THE SDS AGAIN BUT IT WAS STILL UNABLE TO CROSS THE LESION. THE SDS WAS REMOVED FROM THE PATIENT, AND FOUND THAT A PART OF THE STENT STRUT HAS BEEN FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. AFTER PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED WITH A 2.5MM BALLOON CATHETER, THE 3.00 X 12 MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. THERE WAS DIFFICULTY CROSSING THE LESION AS THE GUIDE CATHETER WAS NOT ENGAGED PROPERLY. ANOTHER GUIDEWIRE WAS USED AS A SUPPORT, AND ADVANCED THE SDS AGAIN BUT IT WAS STILL UNABLE TO CROSS THE LESION. THE SDS WAS REMOVED FROM THE PATIENT, AND FOUND THAT A PART OF THE STENT STRUT HAS BEEN FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201287 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312300 14966293

    Patients

    Seq Age Sex Outcome Treatment
    1