BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3043325 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02067
    Event Type
    Death
    Date Received
    April 9, 2013
    Date of Event
    September 6, 2012
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS MDR ID#: 2134265-2010-04770, 2134265-2010-03759, 2134265-2010-03921, 2134265-2010-03922. SAME CASE AS MDR ID#: 2134265-2013-00556, 2134265-2013-00557, 2134265-2013-02066. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD CARDIOPULMONARY ARREST AND EXPIRED. IN (B)(6) 2010, THE PATIENT HAD A GROSSLY ABNORMAL PERSANTINE STRESS TEST REVEALING MID-INFEROLATERAL, INFERIOR AND MID-INFEROSEPTAL ISCHEMIA. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA (CCS CLASS 2) AND SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH (OM1) WITH 90% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF TWO OVERLAPPING TAXUS LIBERTE STENTS, WITH ONE 3.0X16MM STENT PLACED PROXIMALLY AND ANOTHER 2.5X32MM STENT PLACED DISTALLY. INTRAVASCULAR ULTRASOUND REVEALED INCOMPLETE APPOSITION AND THE STENTS WERE POST-DILATED WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, A 2.25X16MM TAXUS STENT WAS IMPLANTED IN THE OSTIAL POSTERIOR DESCENDING ARTERY (PDA). IN (B)(6) 2012, A 3.00X12MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL BRANCH (OM1). IN (B)(6) 2012, THE PATIENT WAS FOUND UNRESPONSIVE AT HOME AND EMS WAS CALLED. THE PATIENT WAS FOUND TO BE IN ASYSTOLE AND WAS DIAGNOSED WITH CARDIOPULMONARY ARREST. THE PATIENT WAS INTUBATED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. ON ARRIVAL TO THE EMERGENCY DEPARTMENT, CPR WAS CONTINUED AND THE PATIENT'S ENDOTRACHEAL TUBE WAS WITHDRAWN. THE PATIENT CONTINUED TO BE IN ASYSTOLE AND WAS GIVEN MEDICATIONS FOR THE SAME. PERICARDIOCENTESIS WAS PERFORMED WITHOUT SIGNIFICANT FLUID ASPIRATION. THE PATIENT'S GLUCOSE WAS WITHIN NORMAL LIMIT. THE PATIENT'S CONDITION DID NOT IMPROVE AND EXPIRED DUE TO "STENT THROMBOSIS OF STENTS IMPLANTED IN 2010 AND RESTENOSIS PROCEDURE PERFORMED IN (B)(6) 2010 AND (B)(6) 2012". AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND PRASUGREL BUT NOT ON THE STUDY DRUG. THE STUDY DRUG WAS LAST TAKEN IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146205 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death 2.50X32MM TAXUS LIBERTE STENT| 2.25X16MM TAXUS STENT| 3.00X16MM TAXUS LIBERTE STENT