BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3724756 · Received December 16, 2013

    Report

    Report Number
    9681442-2013-00130
    Event Type
    Malfunction
    Date Received
    December 16, 2013
    Date of Event
    November 13, 2013
    Report Date
    November 20, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATIONS 21 CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER # P080007. THE LOT NUMBER HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO DEPLOY IN THE RIGHT EXTERNAL ILIAC ARTERY. AFTER PRE-DILATION, THE DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION VIA THE RIGHT FEMORAL ARTERY. AFTER BEING RELEASED 5CM, THE DEPLOYMENT OF THE STENT COULD NOT BE CONTINUED. DURING FURTHER ATTEMPTS TO COMPLETE THE STENT DEPLOYMENT, THE OUTER SHEATH OF THE DELIVERY SYSTEM BROKE. A PTA BALLOON WAS USED TO SECURE THE PARTIALLY RELEASED STENT. FINALLY, THE STENT COULD BE COMPLETELY DEPLOYED BUT WAS FOUND OT BE ELONGATED 2 CM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657087 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWH3379

    Patients

    Seq Age Sex Outcome Treatment
    1