BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1813432 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03617
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    June 16, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    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) - EXAMINATION FOUND THAT THE HYPOTUBE HAD BROKEN APPROXIMATELY 22.5CM FROM THE CATHETER'S STRAIN RELIEF. THE HYPOTUBE WAS ATTACHED AS HANGING BY THE COATING. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. MICROSCOPIC EXAMINATION OF THE BALLOON FOUND NO ISSUES WITH THE BALLOON MATERIAL, TIP OR THE CRIMPED STENT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. SOLIDIFIED BLOOD WAS PRESENT ON THE TIP, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. NO ADDITIONAL PRODUCT ANALYSIS OR EXTERNAL EVALUATIONS WERE PERFORMED. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED (B)(6) 2010. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT WOULD NOT CROSS THE LESION. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD). DURING THE PROCEDURE, THE PHYSICIAN COULD NOT CROSS A 2.75X28MM PROMUS ELEMENT STENT TO THE TARGET LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. ANALYSIS OF THE RETURNED DEVICE REVEALED A SHAFT FRACTURE. 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 H7493911328270 13178143

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR