BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1610254 · Received February 12, 2010

    Report

    Report Number
    2024168-2010-00257
    Event Type
    Injury
    Date Received
    February 12, 2010
    Date of Event
    January 10, 2010
    Report Date
    January 18, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE SECOND RX XIENCE V 3.0 X 23 MM (PART#1009529-23/LOT#9031061) MENTIONED IS BEING FILED UNDER THE SAME MFR NUMBER. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). FURTHER, THESE PT EFFECTS ALONG WITH HOSPITALIZATION, ARE LISTED IN THE NO FAULT RISK ASSESSMENT AS NO-FAULT POST-PROCEDURE COMPLICATIONS. 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 MFR, DESIGN OR LABELING.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2009, THE PT UNDERWENT STENTING OF THE PRE-DILATED PROXIMAL CIRCUMFLEX ARTERY WITH TWO XIENCE V STENTS ALONG WITH STENTING TO THE PRE-DILATED RIGHT POSTERIOR DESCENDING ARTERY WITH ONE XIENCE V STENT. ON (B) (6) 2010, THE PT EXPERIENCED RECURRENCE OF EFFORT ANGINA. THE PT WAS HOSPITALIZED ON (B) (6) 2010, PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED, RESULTS NOT REPORTED. THE PT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION TO THE PROXIMAL CIRCUMFLEX ARTERY ON (B) (6) 2010. THE PT WAS DISCHARGED ON (B) (6) 2010. THERE IS NO ADDITIONAL EVENT OR PT INFO AVAILABLE.

    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 8111441

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R LOT#9031061)| RX XIENCE V 3.0 X 23 MM (PART#1009529-23/