BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1615183 · Received February 23, 2010

    Report

    Report Number
    2024168-2010-00333
    Event Type
    Injury
    Date Received
    February 23, 2010
    Date of Event
    January 27, 2010
    Report Date
    January 29, 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). RESULTS AND CONCLUSIONS SUMMATION - IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECT OF ANGINA AND RESTENOSIS, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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 - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL, THAT THE 2.5 X 28 MM XIENCE V STENT WAS IMPLANTED IN THE MID LEFT ASCENDING DIAGONAL (LAD) ON (B) (6) 2008. ON (B) (6) 2010, THE PT WAS HOSPITALIZED FOR UNSTABLE ANGINA. FUNCTIONAL STRESS TEST WAS POSITIVE. LAB TESTS, PERFORMED ON (B) (6) 2010, INCLUDED TROPONIN I OF 0.06 NG/ML (NUL 0.05). AN ANGIOGRAM WAS PERFORMED ON (B) (6) 2010, SHOWING THAT GREATER THAN 70% MID LAD HAD RESTENOSIS; THEREFORE, THE TARGET LESION WAS REVASCULARIZED USING A XIENCE STENT IMPLANT. NO ADD'L INFO WAS 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 71130P5

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R