BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3781977 · Received April 30, 2014

    Report

    Report Number
    2024168-2014-02707
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    December 10, 2013
    Report Date
    April 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS RECEIVED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SIMILAR INCIDENT QUERY IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT WAS NOT PERFORMED AS THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (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 REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION, AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRE-PROCEDURAL BASELINE ELECTROCARDIOGRAM (ECG) DISPLAYED AN ST ELEVATED MYOCARDIAL INFARCTION (MI). FOLLOWING THE CORONARY INTERVENTION AND POST SUCCESSFUL IMPLANTATION OF A 2.5X15 XIENCE PRIME STENT IN THE DISTAL CIRCUMFLEX (CX) CORONARY ARTERY, THE PATIENT EXPERIENCED A ELEVATION IN CARDIAC ENZYMES AND WAS DIAGNOSED WITH A NON-ST ELEVATED MI. THERE WAS NO REPORTED TREATMENT OR PROLONGED HOSPITALIZATION. THE MI RESOLVED WITHOUT SEQUELA ON (B)(6) 2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259421 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3041741

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability ASPIRIN, CLOPIDOGREL