BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3734732 · Received April 8, 2014

    Report

    Report Number
    2024168-2014-02193
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 18, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RELEVANT TESTS: (B)(6) 2014 (15:56): CK=109 U/L, NORMAL UPPER LIMIT 176; (B)(6) 2014 (01:43): CK-MB=4.2 NG/ML, NORMAL UPPER LIMIT 5.0; (B)(6) 2014 (15:56): CK-MB=5.4 NG/ML, NORMAL UPPER LIMIT 5.0. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE XIENCE XPEDITION SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE. THE ELECTRONIC LOT HISTORY RECORD WAS REVIEWED FOR THE REPORTED LOT AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROXIMAL CIRCUMFLEX STENTING PROCEDURE, A 2.25X28MM XIENCE XPEDITION STENT WAS IMPLANTED AND AN EDGE DISSECTION WAS NOTED. A SECOND UNPLANNED XIENCE XPEDITION STENT WAS IMPLANTED TO TREAT THE DISSECTION. THE FOLLOWING DAY, THE PATIENT EXPERIENCED NON-SERIOUS CREATININE KINASE-MYOCARDIAL BAND (CK-MB) ELEVATION, LESS THAN 2 TIMES THE NORMAL UPPER LIMIT. THERE WAS NO REPORTED TREATMENT. THE ELEVATED ENZYMES RESOLVED WITHOUT ADDITIONAL SEQUELA AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY AS ONSET. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211144 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 211194A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention STENT: XIENCE XPEDITION 2.5X12MM