BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5530580 · Received March 28, 2016

    Report

    Report Number
    2024168-2016-02012
    Event Type
    Injury
    Date Received
    March 28, 2016
    Date of Event
    December 26, 2014
    Report Date
    March 28, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LAB DATA: ON (B)(6) 2014 (06:34): CK=52 U/L, NORMAL UPPER LIMIT 200. ON (B)(6) 2014 (06:34): CK-MB=5.0 NG/ML, NORMAL UPPER LIMIT 5.0. CONCOMITANT PRODUCTS: DILATATION CATHETER: EMERGE 2.5X8, NC EUPHORA 3.75X8. (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. DISSECTION IS LISTED IN THE XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, A 3.5X15MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED IN THE DISTAL CIRCUMFLEX (CX) CORONARY ARTERY. FOLLOWING, A HAZY AREA IN THE MID CX WAS NOTED AND WAS TREATED WITH A 3.5X12MM XIENCE ALPINE STENT, RESOLVING THE DISSECTION. ANOTHER 3.5X12MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL CX CORONARY ARTERY LESION. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED HOME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186523 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4070841

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention