BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION?

    MDR report key: 3221755 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04836
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR EVALUATION. A MICROSCOPIC EXAMINATION IDENTIFIED DISTAL STENT DAMAGE. ONE STENT STRUT WAS BENT OUTWARDS. NO ISSUES WERE NOTED WITH THE TIP AND BALLOON. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE GROIN. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED UNSPECIFIED VESSEL. A 16MM X 3.50MM ION DRUG ELUTING STENT WAS SELECTED AND ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTICED THAT THE EDGE OF THE STENT HAD FRAYED. THE STENT WAS RETRIEVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE GROIN. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED UNSPECIFIED VESSEL. A 16MM X 3.50MM ION¿ DRUG ELUTING STENT WAS SELECTED AND ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTICED THAT THE EDGE OF THE STENT HAD FRAYED. THE STENT WAS RETRIEVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320645 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902416350 15445157

    Patients

    Seq Age Sex Outcome Treatment
    1