BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2760879 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06070
    Event Type
    Death
    Date Received
    September 26, 2012
    Date of Event
    December 21, 2011
    Report Date
    September 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE STENT IMPLANT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL PROMUS REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF DEATH IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PREVIOUS CORONARY PROCEDURE ON (B)(6) 2008 DURING WHICH A NON-ABBOTT STUDY STENT WAS DEPLOYED SUCCESSFULLY. THE PATIENT WAS DISCHARGED ON (B)(6) 2008. ON (B)(6) 2011, THE PATIENT WAS REHOSPITALIZED FOR WORSENING CORONARY ARTERY DISEASE REPORTED AS THE TARGET VESSEL AND ON (B)(6) 2011 SUFFERED A CARDIAC ARREST ON. ON (B)(6) 2011, A PROMUS STENT WAS PLACED IN A NON-TARGET VESSEL, THE OBTUSE MARGINAL, AND A PROMUS STENT IN THE TARGET VESSEL, THE MID LEFT ANTERIOR DESCENDING ARTERY. THE STUDY STENT IMPLANTED ON (B)(6) 2008 WAS OBSERVED TO BE PATENT. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PNEUMONIA. ON (B)(6) 2011, THE PATIENT EXPERIENCED CONGESTIVE HEART FAILURE. ON (B)(6) 2011, THE PATIENT SUFFERED A CARDIAC ARREST AND EXPIRED ON THAT SAME DAY. 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 76 YR Death STENT: PROMUS