BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2772000 · Received October 4, 2012

    Report

    Report Number
    2134265-2012-06028
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 11, 2012
    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

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED DISTAL STENT DAMAGE. ONE STRUT AT THE PROXIMAL EDGE WAS RAISED AND MISALIGNED. ALSO A STRUT ON THE 6TH ROW WAS RAISED AND MISALIGNED. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA). A 3.5 X 28MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE DISTAL RCA. THEN PROXIMAL TO THAT STENT, THIS 3.5 X 28MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM WAS ADVANCED, BUT DURING INSERTION, IT WAS NOTED THAT THE STENT HAD GOTTEN FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA). A 3.5 X 28MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE DISTAL RCA. THEN PROXIMAL TO THAT STENT, THIS 3.5 X 28MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM WAS ADVANCED, BUT DURING INSERTION IT WAS NOTED THAT THE STENT HAD GOTTEN FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328350 15207976

    Patients

    Seq Age Sex Outcome Treatment
    1