BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2143279 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02440
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH STENT DAMAGE. STRUT ROWS TOWARD THE MIDDLE OF THE STENT WERE MISALIGNED. THERE WERE 2 KINKS IN THE HYPOTUBE, 237 AND 544MM DISTAL TO THE CATHETER STRAIN RELIEF (CSR). THERE WAS ALSO A KINK AT THE CSR. THE TIP AND BALLOON SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED ON THE TARGET VESSEL. FOLLOWING IVUS, A 4.00X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS BEING PREPPED WHEN THE PHYSICIAN NOTICED THAT THE MIDDLE OF THE STENT WAS DAMAGED. THE PROMUS ELEMENT DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 4.00X38MM PROMUS ELEMENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED ON THE TARGET VESSEL. FOLLOWING IVUS, A 4.00X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS BEING PREPPED WHEN THE PHYSICIAN NOTICED THAT THE MIDDLE OF THE STENT WAS DAMAGED. THE PROMUS ELEMENT DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 4.00X38MM PROMUS ELEMENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS 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 - GALWAY H7493911338400 0014119153

    Patients

    Seq Age Sex Outcome Treatment
    1