BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1982524 · Received February 9, 2011

    Report

    Report Number
    2024168-2011-00782
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 STENT: 2.5 X 15 MM XIENCE V (PART#1009539-15/LOT#9092841/SERIAL#(B)(4)), 2.5 X 12 MM XIENCE V (PART#1009539-12/LOT#9092341/SERIAL#(B)(4)) THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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. SINCE IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED TO TREAT RESTENOSIS OF A BYPASS GRAFT, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: THE XIENCE V STENT IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. THE IFU CAUTIONS THAT: THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. IT IS UNKNOWN HOW, IF AT ALL, THE USE OF THE DEVICE IN A RESTENOSED GRAFT MAY HAVE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS OCCURRING APPROXIMATELY TWELVE MONTHS AFTER THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2010, THE PATIENT UNDERWENT STENTING IN THE PRE-DILATED, RESTENOSED, SECOND DIAGONAL ARTERY BYPASS GRAFT WITH THREE XIENCE V STENTS, SIZES 2.5 X 28 MM, 2.5 X 15 MM, AND 2.5 X 12 MM. ON (B)(6) 2011, THE PATIENT EXPERIENCED UNSTABLE ANGINA WITH SUBSTERNAL CHEST DISCOMFORT. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE INDEX TARGET LESION WITH AN ADDITIONAL 2.5 X 18 MM XIENCE STENT. THE EVENT RESOLVED ON (B)(6) 2011 AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 9090141

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R