BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3800772 · Received May 8, 2014

    Report

    Report Number
    2024168-2014-02940
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF ANGINA AND MYOCARDIAL INFARCTION, AS LISTED IN XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE IS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A XIENCE XPEDITION OTW STENT WAS IMPLANTED IN A DISTAL RIGHT CORONARY ARTERY (RCA) AND APPROXIMATELY 8 MONTHS LATER, AT A FOLLOWUP VISIT, THE PATIENT COMPLAINED OF ANGINA AND AN ELECTROCARDIOGRAM (ECG) WAS DONE. THE PATIENT WAS DIAGNOSED WITH A Q WAVE/NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). THERE WAS NO TREATMENT PROVIDED AND NO HOSPITALIZATION REPORTED. THE MI RESOLVED THE SAME DAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, ADDITIONAL INFORMATION INDICATED THAT THE MYOCARDIAL INFARCTION BEGAN ON (B)(6) 2014 AND THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS DISCHARGED ON (B)(6) 2014.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED THAT ON (B)(4) 2014, THE PATIENT WAS ALREADY HOSPITALIZED WHEN THE MYOCARDIAL INFARCTION (MI) OCCURRED. ON (B)(4) 2014, MEDICATION WAS GIVEN. ON (B)(4) 2014, THE PATIENT EXPERIENCED ELEVATED TROPONIN, LESS THAN 2 TIMES THE NORMAL LIMIT WITHOUT REPORTED TREATMENT. ON (B)(4) 2014, THE MI RESOLVED WITHOUT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278904 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3011641

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R| S