BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2854908 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07640
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 8, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. THE UNKNOWN XIENCE STENT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF RESTENOSIS, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT 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 THE INDEX PROCEDURE WAS IN (B)(6) 2010. A PROMUS STENT WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE PATIENT HAD A SECONDARY PROCEDURE, ON AN UNKNOWN DATE AT A SECONDARY FACILITY, AND HAD A XIENCE STENT IMPLANTED IN THE CIRCUMFLEX (CX). THE PATIENT WAS ADMITTED ON (B)(6) 2012 AND WAS FOUND TO HAVE IN-STENT RESTENOSIS OF BOTH THE PROMUS AND XIENCE STENTS IN THE DISTAL RCA AND CX. TWO NON-ABBOTT STENTS WERE IMPLANTED TO TREAT THE IN-STENT RESTENOSIS. THERE WERE NO ISSUES OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R STENT: UNKNOWN XIENCE