BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2863374 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07744
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 8, 2012
    Report Date
    November 13, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF BRADYCARDIA IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE XIENCE V EVERLOIMUS ELUTING CORONARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE (IFU). IT SHOULD BE NOTED THE IFU STATES: XIENCE V IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. 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 ON (B)(6) 2008, A XIENCE V STENT WAS IMPLANTED IN A RE-STENOSED, PROXIMAL, LEFT CIRCUMFLEX ARTERY WITH DIRECT STENTING AND APPROXIMATELY 4 YEARS LATER, ON (B)(6) 2012, AFTER THE PATIENTS SON DIED UNEXPECTEDLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EXACERBATED CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND BRADYCARDIA. THE PATIENT WAS TREATED WITH MEDICATIONS AND A PERMANENT PACEMAKER WAS INSERTED. AN ELECTROCARDIOGRAM (ECG) WAS DONE WITH NO MYOCARDIAL INFARCTION FINDINGS. THE SYMPTOMS RESOLVED ON (B)(6) 2012 AND THE PATIENT WAS DISCHARGED HOME. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8070961

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R