BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1591160 · Received January 27, 2010

    Report

    Report Number
    2024168-2010-00120
    Event Type
    Injury
    Date Received
    January 27, 2010
    Date of Event
    December 22, 2009
    Report Date
    January 3, 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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE TWO ADDITIONAL RX XIENCE V STENTS (PART# 1009542-18/LOT# 9091061) AND RX XIENCE V (PART# 1009540-12/LOT# 9092141) MENTIONED ARE BEING FILED UNDER THE SAME MANUFACTURER NUMBER. IN THE CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. ALLERGIC REACTION AND NAUSEA ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) AND NO FAULT RISK ASSESSMENT. 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.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: ALLERGIC REACTION REQUIRING MEDICATION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT ONE DAY POST XIENCE V STENT IMPLANT(S) IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND DISTAL CIRCUMFLEX ARTERIES, THE PATIENT BECAME NAUSEOUS, DEVELOPED A RASH ON BOTH HANDS, AND THE PATIENT'S FACE BECAME SWOLLEN. THE PATIENT WAS TREATED WITH MEDICATION; HOWEVER, THE CONDITION IS CONTINUING. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS 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 9052041

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention RX XIENCE V (PART# 1009540-12/LOT# 9092141)| RX XIENCE V (PART# 1009542-18/LOT# 9091061)