BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1591094 · Received January 26, 2010

    Report

    Report Number
    2024168-2010-00117
    Event Type
    Injury
    Date Received
    January 26, 2010
    Date of Event
    June 30, 2009
    Report Date
    January 2, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE ADD'L RX XIENCE V 3.0 X 28 MM (PART# 1009541-28/LOT# 8053041) AND RX XIENCE V 3.5 X 08 MM (PART# 1009542-08/LOT# 8072861) STENTS ARE BEING FILED UNDER THE SAME MANUFACTURER NUMBER. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECTS ARE KNOWN ADVERSE EVENTS LISTED IN THE RISK ASSESSMENT. 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.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-SURGICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2008, TWO 3.0 X 28 MM RX XIENCE V STENTS AND A 3.5 X 08 MM XIENCE V STENT WERE IMPLANTED IN THE PT. IN (B) (6) 2009, THE PT HAD CHEST PAIN AND WAS ADMITTED TO THE HOSPITAL. CARDIAC CATHETERIZATION AND BYPASS SURGERY WERE PERFORMED TO TREAT RESTENOSIS. NO ADD'L EVENT OR PT INFO 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 8043061

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R| S RX XIENCE V 3.5 X 08 MM| (PART# 1009541-28/LOT# 8053041)| RX XIENCE V 3.0 X 28 MM| (PART# 1009542-08/LOT# 8072861)