BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3090657 · Received May 2, 2013

    Report

    Report Number
    2024168-2013-02728
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE FIRST DIAGONAL BRANCH WITH MILD TORTUOSITY. A XIENCE PRIME STENT WAS PREVIOUSLY IMPLANTED IN THE MID LAD. POST-DILATATION WAS PERFORMED IN THE MID LAD AND THE 2.25 X 12 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE PREVIOUSLY PLACED STENT STRUTS TO THE DIAGONAL BRANCH. THERE WAS NO RESISTANCE NOTED. THE SDS BALLOON WAS INFLATED TO 16 ATMOSPHERES (ATM) FOR 60 SECONDS. AFTER THE SDS BALLOON WAS DEFLATED, THE DEVICE WAS ATTEMPTED TO BE REMOVED, BUT BECAME STUCK WITH THE STENT STRUTS. THE BALLOON WAS INFLATED AND DEFLATED A COUPLE OF TIMES, BUT THE SDS COULD NOT BE REMOVED. AT THIS TIME, THE GUIDING CATHETER BECAME DEEPLY ENGAGED, AND THE SDS WAS REMOVED. IT COULD NOT BE DETERMINED IF THE BALLOON WAS RE-WRAPPED OR DEFLATED FLAT WHEN THE SDS WAS FINALLY REMOVED. THERE WAS NO PORTION OF BALLOON MATERIAL LEFT IN THE ANATOMY. 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
    191120 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101141

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR GUIDE WIRE: JOKER,SION BLUEGUIDE CATH: TAIGA