BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA?

    MDR report key: 3222236 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-05018
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIP
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: DEVICE WAS RECEIVED WITH HANDLE OPEN. MIDDLE SHAFT MOVED FREELY IN OUTER SHAFT WITH NO RESISTANCE. PROXIMAL INNER MOVED FREELY IN MIDDLE SHAFT WITH NOT RESISTANCE. NO KINKS OR DAMAGE WERE NOTED ON THE SHAFT. THUMBWHEEL ROTATED FREELY IN HANDLE HALF WHEN INSERTED. DAMAGE TO RACK DISTAL TOOTH AND HANDLE HOUSING PINS WERE DEFORMED SLIGHTLY. 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 FURTHER REPORTED THAT THE 25CM, 70-80% STEONOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN DEPLOYED 12CM OF THE STENT BEFORE COMPLETING THE DEPLOYMENT MANUALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED. THE LESION BEING TREATED WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN ADVANCED A 6X201X130 INNOVA STENT DELIVERY SYSTEM TO THE TARGET LESION. THE PHYSICIAN BEGAN RELEASING THE STENT, HOWEVER AT ABOUT 1200 MM THE STENT WAS UNABLE TO BE FULLY DEPLOYED. THE DELIVERY SYSTEM WAS TAKEN APART AND THE STENT WAS FULLY DEPLOYED MANUALLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 25CM, 70-80% STEONOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN DEPLOYED 12CM OF THE STENT BEFORE COMPLETING THE DEPLOYMENT MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324255 INNOVA? STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC - MAPLE GROVE H74939181062030

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR