BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC¿ VASCULAR

    MDR report key: 2904208 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08211
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 24, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    P110035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE EPIC STENT DELIVERY SYSTEM (SDS) WAS RECEIVED INSIDE A NON-BSC INTRODUCER SHEATH. THE PULLBACK GRIP WAS FULLY EXTENDED. THE DISTAL END OF THE INNER SHAFT WAS BUCKLED. THERE WAS A COMPLETE INNER SHAFT SEPARATION 6.5CM FROM END OF THE OUTER SHAFT. THE PORTION OF THE INNER SHAFT DISTAL TO THE SEPARATION (INCLUDING THE TIP, FLOATING BUMPER AND FIXED BUMPER) WAS NOT RECEIVED FOR ANALYSIS. MAGNIFIED INSPECTION CONFIRMED THAT THE FRACTURED END OF THE INNER SHAFT WAS JAGGED, CONSISTENT WITH DUCTILE DEFORMATION DUE TO TENSILE OVERLOAD. THE OUTER DIAMETER (OD) OF THE DISTAL OUTER SHAFT WAS MEASURED AND FOUND TO MEET SPECIFICATION. THE SHAFT OF THE SHEATH WAS TWISTED. THE EPIC SDS WAS INSERTED INTO THE SHEATH AND SUCCESSFULLY LOADED (COMPLETELY THROUGH THE SHEATH) AND WITHDRAWN WITHOUT ENCOUNTERING ANY UNUSUAL RESISTANCE. THERE WAS NO EVIDENCE THAT THE INNER SHAFT SEPARATION OR THE REPORTED DIFFICULTY WAS ATTRIBUTABLE TO ANY MATERIAL OR MANUFACTURING 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2012. IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, CATHETER REMOVAL DIFFICULTIES WITHIN A SHEATH OCCURRED. A 6X19X120 EPIC VASCULAR STENT WAS DEPLOYED SUCCESSFULLY IN A LOWER EXTREMITY ARTERY. DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS), THE CATHETER WAS UNABLE TO BE REMOVED FROM A NON-BSC 6F INTRODUCER SHEATH. THE SDS AND INTRODUCER SHEATH WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS LISTED AS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE DISTAL COMPONENTS OF THE INNER SHAFT WERE DETACHED. ADDITIONAL INFORMATION RECEIVED CONFIRMS THAT THESE COMPONENTS DID NOT DETACH INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10439 EPIC¿ VASCULAR STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939200062020 15306736

    Patients

    Seq Age Sex Outcome Treatment
    1 6F TERUMO INTRODUCER SHEATH