BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2880391 · Received December 19, 2012

    Report

    Report Number
    2134265-2012-07979
    Event Type
    Death
    Date Received
    December 19, 2012
    Date of Event
    August 31, 2012
    Report Date
    November 30, 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. DEVICE EVALUATED BY MANUFACTURER: 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).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPIRED. THE LESION BEING TREATED WAS LOCATED IN A 2.25X12MM, 100% STENOSED, DE NOVO, AND TOTALLY OCCLUDED, BIFURCATED PORTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY HAVING NO CALCIFICATION OR TORTUOSITY WITH A THROMBUS PRESENT. THE LESION WAS PRE-DILATED, AND THEN THE 3.00X20MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE LESION AT 6ATMS. NO POST-DILATION WAS PERFORMED. POST PROCEDURE 0% STENOSIS AND TIMI FLOW WAS 3. FOLLOWING THE INDEX PROCEDURE, A PERICARDIOCENTESIS WAS PERFORMED AFTER AN ECHO EXAMINATION, BUT THE PATIENT HAD BEEN ALREADY IN CARDIAC OR RESPIRATORY ARREST. A CARDIAC CHAMBER WALL RUPTURE OCCURRED AND THE PATIENT EXPIRED. NO AUTOPSY WAS PERFORMED BUT THE PHYSICIAN STATED IT WAS "A FREE WALL RUPTURE IN A LONG TERM INFARCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death