BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 2992969 · Received March 1, 2013

    Report

    Report Number
    9681442-2013-00019
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PHOTO TAKEN FROM AN X-RAY SCREEN WAS PROVIDED FOR EVALUATION. BASED ON THE PHOTO PROVIDED, IT IS CONFIRMED THAT THE PLACED STENT WAS CONSTRICTED, WHICH WAS CAUSED BY A TWISTING OF THE STENT. NO ADDITIONAL IMAGES WERE AVAILABLE FOR EVALUATION. AS NO SPECIFIC LOT NUMBER WAS AVAILABLE, NO SPECIFIC REVIEW OF THE MANUFACTURING RECORDS COULD BE PERFORMED. NO RELEVANT MANUFACTURING PROCESS CHANGES WERE IMPLEMENTED, THAT COULD HAVE LEAD TO THE EVENT REPORTED. A ROOT CAUSE ANALYSIS FOR THIS FAILURE MODE HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE FOR THIS KIND OF EVENT. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED, STENT TWISTING MAY BE CAUSED BY INTERACTIONS OF VARIOUS USE RELATED AND ANATOMICAL FACTORS WITH THE GIVEN STENT DESIGN. DUE TO THE HELICAL STRUCTURE THE STENT MAY HAVE AN INHERENT TENDENCY TO ROTATE CLOCKWISE UPON DEPLOYMENT OF THE DELIVERY SYSTEM. HOWEVER BASED ON THE INFORMATION AVAILABLE A DEFINITE ASSESSMENT CONCERNING THIS MATTER COULD NOT BE MADE. THE IFU STATES: "INITIATE STENT DEPLOYMENT BY ROTATING THE THUMBWHEEL IN THE DIRECTION OF THE ARROWS, WHILE HOLDING THE HANDLE IN A FIXED POSITION. FINAL STENT DEPLOYMENT IS ACHIEVED BY USING THE DEPLOYMENT LEVER. WHILE MAINTAINING A FIXED HANDLE POSITION, PLACE YOUR FINGER IN FRONT OF THE DEPLOYMENT SLIDE AND SLIDE IT FROM THE DISTAL TO PROXIMAL END."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VASCULAR STENT POST DEPLOYMENT OF APPROXIMATELY 2 MONTHS DEMONSTRATED A SIGNIFICANT NARROWING IN THE MIDDLE SECTION OF THE VASCULAR STENT; ACCESS WAS GAINED AND PRE-DILATED WITH A PTA BALLOON, AND WAS EXCHANGED OVER WIRE FOR ANOTHER VASCULAR STENT THAT WAS DEPLOYED SUCCESSFULLY, INSIDE THE INITIAL VASCULAR STENT. THERE¿S NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90682 LIFESTENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

    Patients

    Seq Age Sex Outcome Treatment
    1