BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2478323 · Received February 21, 2012

    Report

    Report Number
    3005325609-2012-00004
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 25, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN REFUSED TO PROVIDE THE PT¿S DATE OF BIRTH AND WEIGHT FOR THE MDR. THIS IS ONE OF TWO EVENTS OF THIS TYPE REPORTED WITH THE 6FR STENT DELIVERY SYSTEM. THE PHYSICIANS DESCRIPTION OF THE EVENT AND THE CATH LAB TECHNICIANS WERE CONFLICTING. THE VESSEL PREPARATION MAY NOT HAVE BEEN PERFORMED PER THE IFU. THE STENT MAY NOT HAVE BEEN FULLY DEPLOYED PRIOR TO INITIATING THE REMOVAL OF THE DELIVERY SYSTEM WHICH MAY HAVE CAUSED THE ELONGATED STENT. THE RETRACTION AND LOCK OF THE THUMB SLIDE PRIOR TO REMOVAL WOULD HAVE BEEN DIFFICULT IF THE STENT WAS NOT FULLY DEPLOYED. THE ROOT CAUSE OF THE EVENT IS UNK DUE TO THE CONFLICTING REPORTS. THE PHYSICIAN HAS SINCE BEEN RE-TRAINED. A CAPA FOR THIS EVENT TYPE HAS BEEN OPENED.

    Description of Event or Problem · 1

    THERE WAS A SPIRAL DISSECTION IN THE COMMON FEMORAL ARTERY DUE TO A BALLOON ANGIOPLASTY OF THE ARTERY. THE PHYSICIAN WAS RELUCTANT TO STENT AND DID SO ONLY UNDER A ¿LAST RESORT¿ SCENARIO IN ORDER TO PREVENT FURTHER INJURY. WHEN HE DEPLOYED THE STENT IN THE COMMON FEMORAL ARTERY THE STENT HYPER ELONGATED. HE BELIEVED THE STENT WAS COMPLETELY DEPLOYED AND HE PROCEEDED. THE PHYSICIAN THEN NOTICED THE CATHETER TIP HAD DETACHED. HE SAID THAT THE TIP WAS IN THE ADIPOSE TISSUE AND NO FURTHER ACTION WAS NEEDED. ADDITIONAL INFO FROM THE CATH LAB TECH REPORTED THAT THE STENT ELONGATED FROM THE ILIAC ARTERY ACROSS THE AORTIC BIFURCATION INTO THE OTHER ILIAC. THE PHYSICIAN BEGAN TO PULL THE CATHETER AND HYPER-EXTENDED THE STENT EVEN FURTHER. THE PHYSICIAN ASKED FOR A SNARE AND ONE WAS NOT AVAILABLE. THE TIP WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-080-120-6F 01178059

    Patients

    Seq Age Sex Outcome Treatment
    1