BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2830758 · Received November 13, 2012

    Report

    Report Number
    2024168-2012-07163
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    July 3, 2012
    Report Date
    October 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION, AND THROMBOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH 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. THE ADDITIONAL XIENCE NANO STENT, REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, AFTER IMPLANTATION OF 2 XIENCE NANO STENTS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD), PER ANGIOGRAPHY, SOME LIGHT STAINING COULD BE SEEN AT THE PROXIMAL END OF THE MOST PROXIMAL STENT (LOT 1072141). AT THE TIME, IT WAS FELT TO BE A MINOR DISSECTION AND NO INTERVENTION WAS PERFORMED. EFFIENT WAS STARTED AND THE PATIENT WAS, REPORTEDLY, COMPLIANT WITH THE MEDICATION. ON (B)(6) 2012, THE PATIENT PRESENTED EMERGENTLY TO THE EMERGENCY ROOM WITH UNSTABLE ANGINA. PER ELECTROCARDIOGRAM, A NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION WAS DIAGNOSED. THE PATIENT WAS TAKEN TO THE CATH LAB WHERE THROMBUS WAS SEEN FROM THE PROXIMAL EDGE OF THE PROXIMAL STENT, INTO THE DISTAL VESSEL, FULLY OCCLUDING THE VESSEL. BALLOON ANGIOPLASTY WAS PERFORMED AND A 2.25X08MM XIENCE NANO STENT WAS IMPLANTED PROXIMAL TO THE PROXIMAL STENT AND OVERLAPPING, RESOLVING THE EVENT. THERE WAS NO ADDITIONAL SEQUELA REPORTED AND 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 2030741

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R| S STENT: 2.25X12MM XIENCE NANO STENT