BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2760658 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06064
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS, AS LISTED IN THE XIENCE PRIME INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST XIENCE PRIME STENT IMPLANTATION IN THE CIRCUMFLEX, PLAVIX WAS DISCONTINUED BECAUSE OF A PLANNED UNRELATED SURGICAL PROCEDURE. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE URELATED PLANNED SURGERY. WHILE HOSPITALIZED, THE PATIENT EXPERIENCED ANGINA. ON (B)(6) 2012, DURING A DIAGNOSTIC ANGIOGRAPHY, STENT THROMBOSIS WAS FOUND IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE THROMBUS WAS SUCTIONED AND ANGIOPLASTY WAS PERFORMED. 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 PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 111104Q

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R