BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3981004 · Received August 5, 2014

    Report

    Report Number
    2024168-2014-04948
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 3.0X23MM AND 3.0X12MM RX XIENCE PRIME STENTS MENTIONED ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. CONCOMITANT PRODUCTS: STENT: XIENCE PRIME 3.0X23, 3.0X12, 3.5X18, 3.5X8, 2.5X12, 2.75X18. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION, AND RESTENOSIS, AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF CORONARY STENTS. 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) 2013, 7 XIENCE PRIME STENTS WERE SUCCESSFULLY IMPLANTED IN THE LEFT MAIN, PROXIMAL RIGHT AND MID LEFT ANTERIOR DESCENDING CORONARY ARTERIES. ON (B)(6) 2014, APPROXIMATELY 9 MONTHS POST STENT IMPLANTATION, THE PATIENT EXPERIENCED RECURRENT TYPICAL ANGINA, LASTING MORE THAN 10 MINUTES AND WAS HOSPITALIZED. BIOMARKERS WERE ELEVATED AND A MYOCARDIAL INFARCTION WAS DIAGNOSED. A DIAGNOSTIC CORONARY ANGIOGRAM WAS PERFORMED. THE 3 STENTS IMPLANTED IN THE LEFT MAIN (LEFT MAIN, PROXIMAL LEFT CIRCUMFLEX, PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY) WERE FOUND TO BE RESTENOSED. CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456660 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3070541

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R| S CONCOMITANT MEDICAL DEVICES