BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT CORONARY

    MDR report key: 3010372 · Received March 19, 2013

    Report

    Report Number
    9616099-2013-00149
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: THE MONTH AND DATE ARE ENTERED AS (B)(6) 2004, HOWEVER, PLEASE NOTE THAT THE IMPLANT MONTH/DATE ARE UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY MEDICAL AFFAIRS, AN UNKNOWN CORDIS STENT WAS IMPLANTED DUE TO CHEST PAIN. IT IS UNKNOWN THE LOCATION OR VESSEL TREATED WITH THE CORDIS STENT. THEN APPROXIMATELY NINE YEARS AFTER THE CORDIS STENT WAS IMPLANTED, THE PATIENT EXPERIENCING CHEST AND THROAT PAIN. HE WAS ADMITTED TO THE HOSPITAL AND A BOSTON SCIENTIFIC STENT WAS PLACED IN UNKNOWN LOCATION. HE BEGAN TAKING PLAVIX DAILY. EVENT RESOLVED. THE PATIENT HAS A MEDICAL HISTORY OF SMOKING MULTIPLE PACKS PER DAY FOR 50 YEARS, DIABETES, HEART ATTACK AT AGE (B)(6), DEPRESSION AND MULTIPLE UNSPECIFIED CONDITIONS. THE PRODUCT WAS NOT AVAILABLE FOR TESTING SINCE IT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CORONARY ARTERY DISEASE. BASED ON THE LIMITED INFORMATION AVAILABLE THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED BY MEDICAL AFFAIRS, A PATIENT REPORTED NINE YEARS AFTER CORONARY STENT IMPLANTATION, HE WAS TRANSPORTED VIA RESCUE SQUAD TO EMERGENCY ROOM FOR CHEST AND THROAT PAIN. HE WAS ADMITTED AND A BOSTON SCIENTIFIC STENT WAS PLACED IN UNKNOWN LOCATION. HE BEGAN TAKING PLAVIX DAILY. EVENT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113887 STENT CORONARY CORONARY SDS/STENTS MAF CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR