BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2895181 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00026
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE V/XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS INDICATED AS NOT RETURNING. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS AGO, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF A 3.5 X 18 MM XIENCE V STENT IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. ON (B)(6) 2012, THE PATIENT EXPERIENCED CHEST PAIN AND A STRESS TEST WAS PERFORMED. CORONARY ANGIOGRAPHY WAS PERFORMED AND RESTENOSIS WAS NOTED. A NON-ABBOTT STENT WAS IMPLANTED TO TREAT THE RESTENOSIS. PER THE PHYSICIAN, HE BELIEVES HE OVER-SIZED THE VESSEL DURING IMPLANTATION OF THE 3.5 X 18 MM XIENCE V STENT AND ATTRIBUTES THE RESTENOSIS TO THE OVER-SIZING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3016 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention