BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 3170242 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03721
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    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). DATE OF EVENT AND IMPLANT DATE - ESTIMATIONS ON INITIAL MEDWATCH REPORT. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. 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 IN THE PROXIMAL LEFT MAIN (LM) WITH HEAVY CALCIFICATION. THE XIENCE PRO STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT BE DELIVERED PAST A HEAVILY CALCIFIED PORTION IN THE LEFT MAIN STEM (LMS). THE SDS BECAME CAUGHT ON THE CALCIUM IN THE LMS; THEREFORE, THE SDS WAS PULLED WHICH CAUSED THE GUIDING CATHETER TO ENTER THE LMS. THE FORCE EXERTED ON THE SDS BY THE GUIDING CATHETER CAUSED THE STENT TO ACCORDION. THE SDS WAS NOT ABLE TO BE ADVANCED FURTHER INTO THE LM; THEREFORE, THE STENT WAS DEPLOYED THERE. NO PORTION OF THE STENT WAS DEPLOYED IN HEALTHY TISSUE. AN ADDITIONAL XIENCE PRO STENT WAS IMPLANTED DISTALLY TO FULLY COVER THE LESION. THE PHYSICIAN COMMENTED THAT BOTH STENTS WERE NEEDED TO TREAT THE TARGET LESION AND THE PROCEDURE HAD A GOOD ANGIOGRAPHIC RESULT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272055 XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1