BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 3913383 · Received July 3, 2014

    Report

    Report Number
    2024168-2014-04353
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE XIENCE PRO IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN A LEFT MAIN (LM) BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND AN ANGULATED CIRCUMFLEX (CX). THE PATIENT WAS IN STRESS AND GOING INTO CARDIOGENIC SHOCK AND PULMONARY EDEMA. A T AND SMALL PROTRUSION (TAP) STENTING STRATEGY WAS PERFORMED. THE 2.75X12 MM XIENCE PRO STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE CX UP TO THE OSTIUM AND TAP WITH A 4.0X15 MM XIENCE FROM THE PROXIMAL LAD ACROSS THE BIFURCATION TO THE OSTIUM OF THE LM STEM. THE 2.75X12 MM XIENCE PRO SDS WAS ADVANCED TO THE CX WITH A 3.0 MM DIAMETER BALLOON CATHETER ALSO IN THE LM STEM/LAD. THE STENT DELIVERY SYSTEM WOULD NOT CROSS AND WAS RETRACTED FROM THE ANATOMY. RESISTANCE WAS FELT DURING RETRACTION OF THE SDS INSIDE THE GUIDING CATHETER DUE TO THE ANGULATION OF THE GUIDING CATHETER IN THE ANATOMY. AFTER RETRACTION IT WAS OBSERVED THAT THERE WAS NO STENT ON THE BALLOON. THE STENT IMPLANT COULD NOT BE SEEN ON X-RAY SO ALL THE DEVICES WERE REMOVED FROM THE PATIENT. UPON INVESTIGATION THE SEVERELY MANGLED STENT IMPLANT WAS FOUND INSIDE THE GUIDING CATHETER. A NEW XIENCE SDS WAS USED USING THE SAME TAP STRATEGY TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389737 XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: 4.0X15 MM XIENCE