BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2962495 · Received February 14, 2013

    Report

    Report Number
    2024168-2013-00879
    Event Type
    Death
    Date Received
    February 14, 2013
    Date of Event
    October 19, 2012
    Report Date
    January 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE IS A FORESEEABLE EVENT. HOWEVER, IT WAS INDICATED IN THE REPORTED INFORMATION THAT THE DEATH WAS NOT CARDIAC RELATED AND THE PATIENT DIED OF OTHER COMPLICATIONS. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 U.S. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL/FINAL MEDWATCH FILED, ADDITIONAL INFORMATION PROVIDED AS FOLLOWS: THE IMMEDIATE CAUSE OF DEATH IS NOTED AS SEPTIC SHOCK; THE UNDERLYING CAUSES ARE MENTIONED AS PSEUDOMONAS AERUGINOSA AND ASPIRATION PNEUMONIA. AMONG OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH WERE, END STAGE RENAL DISEASE, IDIOPATHIC THROMBOCYTOPENIC PURPURA AND PANCREATIC MASS. THE INVESTIGATOR CONSIDERED THE EVENT OF SEPTIC SHOCK AS SEVERE IN INTENSITY, AND NOT RELATED TO THE STUDY DRUG, NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO STUDY PROCEDURE.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH FILED, ADDITIONAL INFORMATION AS FOLLOWS: POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW. THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT THE INDEX PROCEDURE ON (B)(6) 2011, DURING WHICH ONE 2.5X18 MM PROMUS STENT WAS DEPLOYED. ON (B)(6) 2012, THE PATIENT'S WIFE REPORTED THAT THE PATIENT HAD DIED OF OTHER COMPLICATIONS; HOWEVER, THE DEATH WAS NOT CARDIAC RELATED. NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65269 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1010461

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death