BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1955445 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00215
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 17, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIL CATH: UNSPECIFIED. GUIDE WIRE: SION BLUE, SUOH, WIZARD1, ULTIMATE BROSS3, CONQUEST PRO, EXTREME, NEO EXTENSION. STENT: ENDEAVOR SPRINT 3.0X30; ENDEAVOR SPRINT 2.5X30; XIENCE V 3.5X15. OTHER: HEPARIN. THE XIENCE V 3.5X15 IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. (B)(4) - PATIENT SELECTION. THE DEVICE REMAINS IN THE PATIENT. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ANGINA AND THROMBOSIS ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. REPORTEDLY, THE XIENCE V STENT WAS USED IN A CHRONIC TOTALLY OCCLUDED LESION. IT SHOULD BE NOTED THAT THE IFU STATES: SAFETY AND EFFECTIVENESS OF THE STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH CHRONIC TOTAL OCCLUSIONS. IT IS UNKNOWN HOW THE USE OF THE XIENCE V IN A TOTALLY OCCLUDED LESION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, TWO XIENCE V STENTS (3.5X15 AND 2.5X28) AND TWO NON-ABBOT STENTS WERE IMPLANTED IN THE DISTAL AND PROXIMAL RIGHT CORONARY ARTERY (RCA) FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION OF 20 YEARS. POST PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. ANGIOGRAPHY REVEALED IN-STENT THROMBOSIS OF THE BOTH XIENCE V STENTS. ON (B)(6) 2010, PERCUTANEOUS INTERVENTION WAS PERFORMED AND DURING THE PROCEDURE, RESISTANCE WITH THE NON-ABBOTT GUIDE WIRE WAS FELT AT THE SITE OF THE 3.5X15 XIENCE V STENT DESCRIBED AS "THE TIP OF GW TOUCHED THE THROMBOSIS", BUT THE PHYSICIAN DID NOT FEEL THE RESISTANCE AT THE SITE OF THE NON-ABBOTT STENT. AT THE SITE OF THE 2.5X28 XIENCE V STENT, THE NON-ABBOTT GUIDE WIRE WAS NOT ABLE TO CROSS THE THROMBOSIS USING A KNUCKLE WIRE TECHNIQUE. ADDITIONALLY, THE PHYSICIAN WAS NOT ABLE TO ASPIRATE THE THROMBOSIS. DILATATION WAS PERFORMED, BUT THERE WAS STILL SOME INDENTATION. A NON-ABBOTT STENT WAS DEPLOYED INSIDE THE IMPLANTED 3.5X15 XIENCE V STENT IN THE PROXIMAL RCA. ON (B)(6) 2010, A NON- ABBOTT STENT WAS IMPLANTED IN THE LEFT MAIN TRUNK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R