BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3222325 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04319
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION, AND RESTENOSIS, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE ARE KNOWN PATIENT EFFECTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2013 WHICH REVEALED 99% IN-STENT RESTENOSIS OF A NON-ABBOTT STENT IN THE PROXIMAL LCX. THE RESTENOSIS WAS TREATED WITH BALLOON DILATATIONS AND A 3.0 X 28 MM XIENCE V STENT. ON (B)(6) 2013, THE PATIENT WAS RE-ADMITTED FOR CHEST PAIN WHICH WAS DIAGNOSED AS A MYOCARDIAL INFARCTION. ON (B)(6) 2013, 90% RE-STENOSIS WAS OBSERVED IN THE LCX WHICH WAS TREATED WITH A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    CORRECTION: THE STENT USED IN THE PROCEDURE WAS A 3.0 X 28 MM XIENCE XPEDITION STENT, NOT A 3.0 X 28 MM XIENCE V STENT AS REPORTED IN THE INITIAL MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323779 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082541

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R STENT: PROMUS ELEMENT