BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1923499 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02722
    Event Type
    Death
    Date Received
    December 13, 2010
    Date of Event
    September 21, 2009
    Report Date
    November 18, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND DEATH ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ADDITIONALLY, ANGINA, DEATH, DYSPNEA, RESPIRATORY DISTRESS, ARE LISTED IN THE DEVICE RISK ASSESSMENT MATRIX. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING OR DESIGN AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE 3.0 X 12 MM PROMUS (1009541-12B/8102061) IS BEING FILED UNDER A SEPARATE MFR#.

    Additional Manufacturer Narrative · 1

    (B)(4).THE REPORTED RENAL FAILURE IS LISTED IN THE INSTRUCTIONS FOR USE AS A KNOWN ADVERSE PATIENT EVENT ASSOCIATED WITH CORONARY STENTING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A WASTE BUCKET FULL ERROR. WHEN THE HYDRO DRAWER WAS PULLED, THE CUSTOMER FOUND THE WASTE HAD SPILLED FROM A TUBE THAT CAME OFF THE WASTE BUCKET. NO INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT 69 DAYS POST INDEX PROCEDURE THE PATIENT EXPERIENCED CARDIAC CHEST PAIN. ON (B)(6) 2010, 356 DAYS POST INDEX PROCEDURE THE PATIENT DIED. THIS WAS REPORTED AS AN UNRELATED CARDIAC DEATH. IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL (OM) WITH 80% STENOSIS AND WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF TWO OVERLAPPING 3.0 X 12 MM STUDY STENTS WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. ADDITIONALLY, IT WAS REPORTED THAT POST INDEX PROCEDURE THE PATIENT EXPERIENCED DEHYDRATION, ACUTE/CHRONIC RENAL FAILURE DUE TO TUBULAR NECROSIS FROM HYPOTENSION AND HYPERKALEMIA ((B)(6) 2010); COMPLAINED OF FEELING SHORT OF BREATH ((B)(6) 2010). THE PATIENT AWOKE (B)(6) 2010 AND BECAME MORE DYSPNEIC AND SUDDENLY COLLAPSED. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED BY FAMILY MEMBERS FOR ABOUT 10 MINUTES UNTIL THE MEDICS ARRIVED. THE PATIENT WAS IN PULSELESS ELECTRICAL ACTIVITY (PEA) AND WAS INTUBATED IN THE FIELD. EPINEPHRINE, ATROPINE AND D50 WERE ADMINISTERED AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. CPR WAS CONTINUED IN THE EMERGENCY ROOM AND EPINEPHRINE AND ATROPINE WERE ADMINISTERED. THE PATIENT REMAINED IN PEA, PUPILS WERE FIXED AND DILATED AND PER ULTRASOUND THERE WAS NO CARDIAC MOVEMENT. THE SUBJECT WAS PRONOUNCED DEAD ON (B)(6) 2010. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    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 8102061

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death STENT: 3.0 X 12 MM PROMUS (1009541-12B/8102061)