BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3170695 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03736
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    June 23, 2012
    Report Date
    May 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF HYPOTENSION, BRADYCARDIA, AND DEATH ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, NEW INFORMATION RECEIVED AS FOLLOWS: THE PATIENT WAS DIAGNOSED WITH RESPIRATORY FAILURE ON (B)(6) 2012. THE PATIENT WAS ALSO DIAGNOSED WITH HYPOTENSION AND BRADYCARDIA WITH WIDE COMPLEX JUNCTIONAL RHYTHM DURING THE COURSE OF THE EVENT. THE PATIENT DEATH ON (B)(6) 2012 WAS DUE TO RESPIRATORY FAILURE WHICH WAS ALSO IN TURN DUE TO CONGESTIVE HEART FAILURE, DUE TO ISCHEMIC CARDIOMYOPATHY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE THAT TOOK PLACE ON (B)(6) 2008 WAS TO TREAT A LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED, WITH A NON-ABBOTT STENT. ON (B)(6) 2009, A 2.5X15 MM UNKNOWN PROMUS STENT WAS IMPLANTED IN THE DISTAL RIGHT POSTERIOR DESCENDING ARTERY FOR TREATMENT OF A NEW 80% STENOSED LESION. ON (B)(6) 2012, 1557 DAYS POST PROCEDURE THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271856 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death