BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC? VASCULAR

    MDR report key: 3922990 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-04047
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIO
    PMA / PMN Number
    P110035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RECEIVED PRODUCT CONSISTED OF AN EPIC DEVICE WITH NO OTHER DEVICES. THE PULL GRIP WAS COMPLETELY PULLED BACK. THE STENT WAS NOT RETURNED FOR ANALYSIS. THE SHAFT WAS KINKED 10.5CM FROM THE TIP. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE AND REPORTED PARTIAL DEPLOYMENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTIAL DEPLOYMENT OF STENT OCCURRED. A 6X100X120 EPIC¿ VASCULAR STENT WAS SELECTED. DURING PREPARATION OF THE DEVICE, THE DISTAL TIP OF THE DELIVERY CATHETER WAS PULLED. IT WAS THEN NOTED THAT THE DISTAL TIP OF THE STENT HAD BEEN PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTIAL DEPLOYMENT OF STENT OCCURRED. A 6X100X120 EPIC VASCULAR STENT WAS SELECTED. DURING PREPARATION OF THE DEVICE, THE DISTAL TIP OF THE DELIVERY CATHETER WAS PULLED. IT WAS THEN NOTED THAT THE DISTAL TIP OF THE STENT HAD BEEN PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400435 EPIC? VASCULAR STENT, ILIAC NIO BOSTON SCIENTIFIC - MAPLE GROVE H74939200061020 16729546

    Patients

    Seq Age Sex Outcome Treatment
    1