BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1923370 · Received December 13, 2010

    Report

    Report Number
    2134265-2010-05505
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED A BREAK IN THE HYPOTUBE 230MM DISTAL TO THE CATHETER STRAIN RELIEF. THERE WERE ALSO KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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 CLASSIFICATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - 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 STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE 99% STENOSED ECCENTRIC DE NOVO LESION MEASURING APPROXIMATELY 2.75MM IN DIAMETER AND 44MM IN LENGTH WAS LOCATED IN A SEVERELY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT CONTAINED A SIGNIFICANT BEND. THE LESION WAS PREDILATED WITH A 2.5X20MM BALLOON WHICH RESULTED IN NO SIGNIFICANT STENOSIS IN THE LESION. A 2.75X16MM PROMUS ELEMENT STENT WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS AFTER MULTIPLE ATTEMPTS AND THE USE OF A BUDDY WIRE. THE SHAFT WAS NOTED TO BE INTACT AND THE PHYSICIAN ATTEMPTED TO USE THE DEVICE TO STENT A SECOND LESION IN THE LEFT CIRCUMFLEX ARTERY WHEN THE DISTAL SHAFT FRACTURED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON BSC STENT AND POST DILATED WITH THE STENT BALLOON. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS LISTED AS STABLE.THIS DEVICE IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE 99% STENOSED ECCENTRIC DE NOVO LESION MEASURING APPROXIMATELY 2.75MM IN DIAMETER AND 44MM IN LENGTH WAS LOCATED IN A SEVERELY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT CONTAINED A SIGNIFICANT BEND. THE LESION WAS PREDILATED WITH A 2.5X20MM BALLOON WHICH RESULTED IN NO SIGNIFICANT STENOSIS IN THE LESION. A 2.75X16MM PROMUS ELEMENT STENT WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS AFTER MULTIPLE ATTEMPTS AND THE USE OF A BUDDY WIRE. THE SHAFT WAS NOTED TO BE INTACT AND THE PHYSICIAN ATTEMPTED TO USE THE DEVICE TO STENT A SECOND LESION IN THE LEFT CIRCUMFLEX ARTERY WHEN THE DISTAL SHAFT FRACTURED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON BSC STENT AND POST DILATED WITH THE STENT BALLOON. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS LISTED AS STABLE. THIS DEVICE 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 H7493911316270 13055454

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 182CM CHOICE PT GRAPHIX GUIDE WIRE| XB 2.5 GUIDE CATHETER