BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5452339 · Received February 22, 2016

    Report

    Report Number
    2024168-2016-01045
    Event Type
    Injury
    Date Received
    February 22, 2016
    Date of Event
    February 11, 2016
    Report Date
    February 22, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RELEVANT TESTS/LABORATORY DATA: (B)(6) 2016 (17:02): TROPONIN I=0.20 NG/ML, UPPER REFERENCE LIMIT 0.05; (B)(6) 2016 (05:08): CK=379 U/L, NORMAL UPPER LIMIT 233; (B)(6) 2016 (05:08): CK-MB=58.5 NG/ML, NORMAL UPPER LIMIT 5.0; (B)(6) 2016 (05:08): TROPONIN I=3.05 NG/ML, UPPER REFERENCE LIMIT 0.05. (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE FOR THE PATIENT EFFECT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. 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 ISSUE WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A CORONARY PROCEDURE WITH IMPLANTATION OF 2.5 X 18 MM XIENCE ALPINE STENT IN THE MID LEFT ANTERIOR DESCENDING ARTERY. POST DEPLOYMENT, PLAQUE SHIFT WAS NOTED PROXIMAL TO THE STENT. A 2.5 X 12 MM XIENCE ALPINE WAS IMPLANTED, IN AN OVERLAPPING FASHION, TO TREAT THE PLAQUE SHIFT, RESOLVING THE EVENT. POST PROCEDURE, THE PATIENT EXPERIENCED AN ENZYME ELEVATION. NO TREATMENT WAS PROVIDED AND THE ENZYME ELEVATION RESOLVED ON (B)(6) 2016. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108556 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 5101441

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention