BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1729702 · Received June 16, 2010

    Report

    Report Number
    2024168-2010-01187
    Event Type
    Injury
    Date Received
    June 16, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 22, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, ISCHEMIA AND STENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT 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. THE XIENCE V (PART 1009539-28, LOT 8041841), IS BEING FILED UNDER THIS MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: RESTENOSIS REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL ON (B) (6) 2008, THE PT UNDERWENT STENTING IN THE PREDILATED DISTAL RIGHT CORONARY ARTERY (RCA) WITH ONE XIENCE V STENT, THE PREDILATED RIGHT POSTERIOR DESCENDING ARTERY (RPDA) WITH ONE XIENCE V STENT, AND THE PREDILATED PROXIMAL SECOND DIAGONAL ARTERY WITH ONE XIENCE V STENT. ON (B) (6) 2010, THE PT EXPERIENCED ANGINA AND A POSITIVE FUNCTIONAL ISCHEMIA STUDY. THE PT UNDERWENT REVASCULARIZATION FOR IN-STENT RESTENOSIS IN THE RCA VIA PERCUTANEOUS CORONARY INTERVENTION BALLOON ANGIOPLASTY FOR IN-STENT RESTENOSIS IN THE RPDA. THE PT'S CLOPIDOGREL WAS CHANGED TO PRASUGREL ON (B) (6) 2010. THE PT'S CONDITION RESOLVED AND WAS DISCHARGED ON (B) (6) 2010. THERE WAS NO ADVERSE PT 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 NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8053061

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention STENT: XIENCE V (PART 1009539-28, LOT 8041841)