BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3030995 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-02272
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RECEIVED INSIDE THE PRODUCT POUCH AND SHELF BOX. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A KINK AT THE MIDSHAFT LOCATED 26CM FROM THE TIP. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE CRIMPED STENT, BALLOON AND TIP 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. 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

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE MODERATELY CALCIFIED, ECCENTRIC, 16MM IN LENGTH, 3MM IN DIAMETER TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS RIGHT CORONARY ARTERY. A 20X3.0MM PROMUS ELEMENT DRUG ELUTING STENT WAS USED TO TREAT THE TARGET LESION. THE STENT WAS UNABLE TO CROSS THE TARGET LESION AND IT WAS NOTED THAT "THE WHOLE OF THE STENT ITSELF GOT KINKED." PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE MODERATELY CALCIFIED, ECCENTRIC, 16MM IN LENGTH, 3MM IN DIAMETER TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS RIGHT CORONARY ARTERY. A 20X3.0MM PROMUS ELEMENT DRUG ELUTING STENT WAS USED TO TREAT THE TARGET LESION. THE STENT WAS UNABLE TO CROSS THE TARGET LESION AND IT WAS NOTED THAT "THE WHOLE OF THE STENT ITSELF GOT KINKED." PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133964 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 0015743476

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR