BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC¿ VASCULAR

    MDR report key: 2972448 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00828
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    P110035
    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 THE SAFETY LOCK THAT IS PLACED ON THE HANDLE WAS IN THE AS-MANUFACTURED POSITION; HOWEVER, IT CANNOT BE DETERMINED IF THE SAFETY LOCK WAS REMOVED THEN REPLACED AFTER UNKNOWN HANDLING/USE OF THE DEVICE. THE STENT WAS PROTRUDING 10MM FROM THE DISTAL TIP OF THE DELIVERY SYSTEM. THE SHAFT WAS KINKED 8CM FROM THE TIP. THE PARTIALLY DEPLOYED STENT IS CONSISTENT WITH THE REPORTED INFORMATION. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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#2134265-2013-00802. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE PREMATURE DEPLOYMENT 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 ANOTHER 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#2134265-2013-00802. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE PREMATURE DEPLOYMENT 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
    76448 EPIC¿ VASCULAR STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939200086020 15598586

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH, COOK 6F FLEXOR BALKIN