BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1953212 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00144
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE 2.5 X 23 MM XIENCE V (1009527-23, 0032641) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS IS LISTED AS A KNOWN ADVERSE EVENT OF CORONARY STENTING IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENOSIS PRE-PROCEDURE WAS 95%. TWO XIENCE V STENTS WERE IMPLANTED. THE 2.5 X 23 MM WAS IMPLANTED IN THE DISTAL PART, AND THE 3.0 X 23 MM WAS IMPLANTED IN THE PROXIMAL PART. THE STENOSIS POST IMPLANTATION WAS 0%. PLAQUE SHIFT AND ACUTE THROMBOSIS WERE NOTED. AN UNSPECIFIED 2.5 X15 MM BALLOON WAS USED AND A 2.5 X 12 MM NON-ABBOTT STENT WAS USED SUCCESSFULLY FOR TREATMENT. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. 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 0032941

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: 2.5 X 23 MM XIENCE V ((B)(4))