BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2894410 · Received January 3, 2013

    Report

    Report Number
    2134265-2012-08142
    Event Type
    Death
    Date Received
    January 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE: (B)(6) 2012. 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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEATH DATE: ORIGINALLY REPORTED AS (B)(6) 2012 AND CORRECTED TO (B)(6) 2012. DESCRIBE EVENT OR PROBLEM, OTHER RELEVANT HISTORY AND PATIENT CODES UPDATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUBSEQUENT TO A STENTING TREATMENT PROCEDURE STENT THROMBOSIS OCCURRED AND THE PATIENT EXPIRED. IN (B)(6) 2012 THE PATIENT PRESENTED WITH AN EMERGENT MYOCARDIAL INFARCTION. A DE NOVO, 2.5MM IN DIAMETER, 15MM IN LENGTH AND 100% STENOSED TARGET LESION WAS IDENTIFIED IN THE MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON CATHETER. A 2.50X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE RCA AND DEPLOYED AT 11 ATMOSPHERES AFTER 20 SECONDS. POST-DILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER. IVUS IMAGING WAS PERFORMED AND THE STENT HAD GOOD APPOSITION WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CILOSTAZOL. IN (B)(6) 2012, THE PATIENT RETURNED AND STENT THROMBOSIS WAS FOUND. A PERCUTANEOUS CARDIOPULMONARY SUPPORT SYSTEM WAS CONNECTED TO THE PATIENT, HOWEVER THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ON (B)(6) 2012, THE PATIENT DEVELOPED RESPIRATORY FAILURE AT HOME AND AN AMBULANCE WAS CALLED. THE PATIENT BECAME PULSELESS ELECTRICAL ACTIVITY (PEA) IN THE AMBULANCE WHILE ON THE WAY TO THE FACILITY. CARDIAC CHEST COMPRESSIONS WERE ADMINISTERED UNTIL ARRIVAL AT THE FACILITY. UPON ADMISSION TO THE FACILITY, AN ELECTROCARDIOGRAM WAS PERFORMED AND AN INFEROPOSTERIOR MYOCARDIAL INFARCTION WAS DIAGNOSED. EPINEPHRINE WAS ADMINISTERED AND THE PATIENT WAS TRANSFERRED TO THE CARDIAC CATHETERIZATION LAB, HOWEVER THE PATIENT BECAME PEA SHORTLY THEREAFTER. THE PATIENT WAS CONNECTED TO A PERCUTANEOUS CARDIOPULMONARY SUPPORT SYSTEM (PCPS) AND CIRCULATION RETURNED. AN 8F NON-BSC THROMBECTOMY DEVICE WAS ADVANCED AND THROMBUS ASPIRATION PERFORMED. INTRAVASCULAR ULTRASOUND WAS ALSO PERFORMED SHOWING THAT NO IN-STENT RESTENOSIS HAD OCCURRED. THE PATIENT WAS TRANSFERRED TO THE ICU. THE FOLLOWING DAY THE PATIENT STILL DID NOT HAVE SPONTANEOUS CIRCULATION AND REMAINED CONNECTED THE PCPS. THE FOLLOWING DAY THE PATIENT EXPERIENCED ANEMIA AND A DECREASE IN PLATELETS AND CONSCIOUSNESS DECREASED. A BLOOD TRANSFUSION WAS PERFORMED. THE FOLLOWING DAY A BLOOD CLOT FORMED IN THE PATIENT'S THROAT AND CAUSED RESPIRATORY FAILURE AND REMAINED CONNECTED THE PCPS. THE FOLLOWING DAY THE PHYSICIAN SPOKE WITH THE PATIENT'S FAMILY AND IT WAS DECIDED TO REMOVE THE PCPS. THE PATIENT DIED SEVERAL HOURS LATER ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320250

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death