BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2080314 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03240
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 3.0 X 12 VOYAGER NC, (B)(6) IS BEING FILED UNDER A SEPARATE MFR NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND THROMBOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RAMUS ARTERY. A 2.5 X 23 XIENCE V STENT WAS DEPLOYED AND POST-DILATATION COMPLETED WITH A 2.75 X 15 VOYAGER NC WITHOUT ISSUE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY AREA. APPROXIMATELY ONE HOUR POST-STENTING PROCEDURE THE PATIENT COMPLAINED OF CRUSHING CHEST PAIN AND THE ANGIOGRAM NOTED STENT THROMBOSIS. THE PATIENT UNDERWENT AN ADDITIONAL PERCUTANEOUS TRANSLUMINAL PROCEDURE WITH AN EXTRACTION CATHETER AND A SECOND STENT PLACED PROXIMALLY. DURING POST-DILATATION INFLATION WITH A 3.0 X 12 VOYAGER NC THE PROXIMAL SHAFT SEPARATED; HOWEVER, THE ENTIRE CATHETER WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS REPORTED AS DOING FINE. THERE WAS NO ADDITIONAL INFORMATION 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 0121641

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention DILATATION CATHETER: 2.75X15 VOYAGER NC