BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3173585 · Received June 17, 2013

    Report

    Report Number
    2134265-2013-04276
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED NO KINKS OR DAMAGE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT WAS PERFORMED. THE BALLOON DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE AND THERE WAS NO ISSUES NOTED WITH THE PROFILE OF THE TIP. 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

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. A 12 X 2.5 UNSPECIFIED BALLOON CATHETER WAS USED FOR PRE-DILATATION. A 3.00X32MM PROMUS ELEMENT PLUS STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN PULLED AND CHECKED THE STENT AND NOTICED THAT THE EDGE OF THE STENT WAS DAMAGED. DILATATION WAS PERFORMED AGAIN WITH THE 12 X 2.5 BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME PROMUS ELEMENT PLUS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. A 12 X 2.5 UNSPECIFIED BALLOON CATHETER WAS USED FOR PRE-DILATATION. A 3.00X32MM PROMUS ELEMENT¿ PLUS STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN PULLED AND CHECKED THE STENT AND NOTICED THAT THE EDGE OF THE STENT WAS DAMAGED. DILATATION WAS PERFORMED AGAIN WITH THE 12 X 2.5 BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME PROMUS ELEMENT¿ PLUS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273061 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918432300 15965024

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR