BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC?

    MDR report key: 4092493 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05556
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE EPIC STENT DELIVERY SYSTEM (SDS) WAS RECEIVED IN TWO PIECES. THE INNER SHAFT WAS TWISTED/TORSIONAL DAMAGE 60MM-70MM FROM THE DISTAL TIP. THE INNER SHAFT WAS COMPLETELY SEPARATED FROM THE SDS. THERE WAS NO DAMAGE OR IRREGULARITIES TO THE HANDLE. THERE WAS NO DAMAGE OR IRREGULARITIES TO THE TIP. THERE WERE NUMEROUS KINKS AND BUCKLED LOCATIONS THROUGHOUT THE OUTER SHEATH. 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 REPORTED THAT A SHAFT BREAK AND REMOVAL DIFFICULTIES OCCURRED. ONE TO TWO WEEKS EARLIER, AN UNSPECIFIED STENT WAS IMPLANTED IN THE RIGHT HEPATIC DUCT TO COMMON BILE DUCT AND ANOTHER UNSPECIFIED STENT WAS IMPLANTED IN THE ANTERIOR SEGMENT. THE PROCEDURE WAS PLANNED TO IMPLANT A STENT IN THE LEFT HEPATIC DUCT TO THE RIGHT HEPATIC DUCT. THE PORTAL DUCT WAS NOTED TO BE TORTUOUS. A 10MM X 60MM X 75MM EPIC SELF-EXPANDING STENT DELIVERY SYSTEM (SDS) WAS INSERTED VIA AN UNSPECIFIED GUIDEWIRE. THE SLIGHT RESISTANCE WAS ENCOUNTERED WHEN CROSSING THE MESH AREA OF THE PREVIOUSLY IMPLANTED STENT IN THE LEFT HEPATIC DUCT TO COMMON BILE DUCT. THE PHYSICIAN CONTINUED TO ADVANCE THE SDS AND IT WAS NOTED THAT THE TIP OF THE EPIC STENT WAS DEPLOYED IN THE UNINTENDED AREA, NEAR THE TARGET LESION AREA. AS A RESULT, THE SDS BECAME UNABLE TO MOVE. THEREFORE, THE PHYSICIAN DEPLOYED THE STENT WHERE THE TIP OF THE STENT HAD DEPLOYED. THE EPIC STENT PARTIALLY COVERED THE TARGET LESION. DURING THE WITHDRAWAL OF THE SDS, THE RESISTANCE WAS ENCOUNTERED AGAIN. WHEN THE SDS WAS PULLED AND REMOVED FROM THE PATIENT, IT WAS NOTED THAT ONLY THE OUTER SHAFT WAS REMOVED AND THE INNER SHAFT REMAINED INSIDE THE PATIENT. CONSEQUENTLY, THE INNER SHAFT WAS REMOVED FROM THE PATIENT BUT THE SECTION WHERE THE STENT WAS DEPLOYED WAS KINKED IN ACCORDION SHAPE. BECAUSE THE STENT MANAGED TO REDUCE THE PATIENT'S JAUNDICE ADDITIONAL INTERVENTION WAS NOT SCHEDULED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHAFT BREAK AND REMOVAL DIFFICULTIES OCCURRED. ONE TO TWO WEEKS EARLIER, AN UNSPECIFIED STENT WAS IMPLANTED IN THE RIGHT HEPATIC DUCT TO COMMON BILE DUCT AND ANOTHER UNSPECIFIED STENT WAS IMPLANTED IN THE ANTERIOR SEGMENT. THE PROCEDURE WAS PLANNED TO IMPLANT A STENT IN THE LEFT HEPATIC DUCT TO THE RIGHT HEPATIC DUCT. THE PORTAL DUCT WAS NOTED TO BE TORTUOUS. A 10MM X 60MM X 75MM EPIC SELF-EXPANDING STENT DELIVERY SYSTEM (SDS) WAS INSERTED VIA AN UNSPECIFIED GUIDEWIRE. THE SLIGHT RESISTANCE WAS ENCOUNTERED WHEN CROSSING THE MESH AREA OF THE PREVIOUSLY IMPLANTED STENT IN THE LEFT HEPATIC DUCT TO COMMON BILE DUCT. THE PHYSICIAN CONTINUED TO ADVANCE THE SDS AND IT WAS NOTED THAT THE TIP OF THE EPIC STENT WAS DEPLOYED IN THE UNINTENDED AREA, NEAR THE TARGET LESION AREA. AS A RESULT, THE SDS BECAME UNABLE TO MOVE. THEREFORE, THE PHYSICIAN DEPLOYED THE STENT WHERE THE TIP OF THE STENT HAD DEPLOYED. THE EPIC STENT PARTIALLY COVERED THE TARGET LESION. DURING THE WITHDRAWAL OF THE SDS, THE RESISTANCE WAS ENCOUNTERED AGAIN. WHEN THE SDS WAS PULLED AND REMOVED FROM THE PATIENT, IT WAS NOTED THAT ONLY THE OUTER SHAFT WAS REMOVED AND THE INNER SHAFT REMAINED INSIDE THE PATIENT. CONSEQUENTLY, THE INNER SHAFT WAS REMOVED FROM THE PATIENT BUT THE SECTION WHERE THE STENT WAS DEPLOYED WAS KINKED IN ACCORDION SHAPE. BECAUSE THE STENT MANAGED TO REDUCE THE PATIENT'S JAUNDICE ADDITIONAL INTERVENTION WAS NOT SCHEDULED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572956 EPIC? STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939054106070 16207753

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention