BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT¿ RP ENDOPROSTHESIS

    MDR report key: 2972444 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00802
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P940019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS FULLY MOUNTED. EXAMINATION OF THE SHAFT OF THE DEVICE NOTED THAT THE OUTER SHEATH WAS BUNCHED UP IN APPEARANCE BETWEEN 204MM AND 212MM AND AGAIN BETWEEN 640MM AND 684MM PROXIMAL TO ITS DISTAL END. IT WAS POSSIBLE TO INSERT A 0.035 INCH GUIDEWIRE THROUGH THE DEVICE WITHOUT ANY ISSUE NOTED. IT WAS POSSIBLE TO PARTIALLY DEPLOY, RECONSTRAINED AND FULLY DEPLOY THE STENT. THERE WAS NO ISSUE NOTED WITH THE MOVEMENT OF THE OUTER SHEATH. EXAMINATION OF THE DEPLOYED STENT FOUND NO ANOMALIES. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2013-00828. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. AS A 8X61X120MM EPIC VASCULAR STENT DELIVERY SYSTEM WAS ENTERING A 6F NON BSC SHEATH, THE STENT PREMATURELY DEPLOYED. THE STENT WAS RESHEATHED AND REMOVED. A 9X18X135MM WALLSTENT RP STENT DELIVERY SYSTEM WAS INSERTED INTO THE 6F NON BSC SHEATH, DIFFICULTY WAS ENCOUNTERED AND THE STENT "WRINKLED". THE WALLSTENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANTHER WALLSTENT RP STENT DELIVERY SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2013-00828. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. AS A 8X61X120MM EPIC VASCULAR STENT DELIVERY SYSTEM WAS ENTERING A 6F NON BSC SHEATH, THE STENT PREMATURELY DEPLOYED. THE STENT WAS RESHEATHED AND REMOVED. A 9X18X135MM WALLSTENT RP STENT DELIVERY SYSTEM WAS INSERTED INTO THE 6F NON BSC SHEATH, DIFFICULTY WAS ENCOUNTERED AND THE STENT "WRINKLED." THE WALLSTENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANTHER WALLSTENT RP STENT DELIVERY SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76766 WALLSTENT¿ RP ENDOPROSTHESIS STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY M001712250 14448658

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH, COOK 6F FLEXOR BALKIN| STENT, 8X61X120MM EPIC VASCULAR