BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2882567 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-08079
    Event Type
    Death
    Date Received
    December 20, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM CORRECTED. DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, AND DEVICE MANUFACTURED DATE UPDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2012-08088 AND 2134265-2012-08089. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A PERFORATION OCCURRED AND THE PATIENT EXPIRED. THERE WERE TWO TARGET LESIONS BEING TREATED. THE FIRST LESION WAS IN THE 3.50MM IN DIAMETER, 24MM IN LENGTH AND 95% STENOSED RIGHT CORONARY ARTERY (RCA) WITH TIMI III FLOW. THE RCA LESION WAS PREDILATED WITH 3 EMERGE BALLOON CATHETERS; A 2.50X30MM, 3.50X20MM AND 3.00X15MM TO 18 ATMOSPHERES FOR 10 SECONDS. TWO PROMUS ELEMENT PLUS STENTS WERE THEN DEPLOYED; A 3.50X28MM AND A 3.50X8MM WITHOUT ISSUE. THE SECOND LESION WAS IN THE 2.25MM IN DIAMETER, 24MM IN LENGTH, 90% STENOSED, BIFURCATED AND MODERATELY CALCIFIED DIAGONAL ARTERY (DA) WITH TIMI III FLOW. TWO NON-BSC GUIDE WIRES WERE ADVANCED TO THE TWO BRANCHES OF THE DA. PREDILATION WITH A 2.00X10MM FLEXTOME CUTTING BALLOON WAS PERFORMED IN EACH BRANCH TO 12 ATMOSPHERES FOR 10 SECONDS. ADDITIONAL PREDILATION WAS PERFORMED WITH A 2.00X30MM EMERGE BALLOON CATHETER TO 16 ATMOSPHERES FOR 10 SECONDS. A 2.25X16MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE DISTAL PART OF A DA BRANCH AND DEPLOYED AT 14 ATMOSPHERES FOR 15 SECONDS. A 2.50X28MM PROMUS ELEMENT PLUS SDS WAS THEN ADVANCED AND DEPLOYED IN THE PROXIMAL PART OF BOTH BRANCHES. THE STENTS WERE DEPLOYED OVERLAPPING ONE ANOTHER. ANGIOGRAPHY WAS REVIEWED AND THE STENT DEPLOYMENT APPEARED SUCCESSFUL. HOWEVER SHORTLY THEREAFTER, A PERFORATION OF THE DA WAS NOTED IN THE AREA WHERE THE STENTS WERE OVERLAPPING AND CONTRAST WAS SEEN OUTSIDE OF THE ARTERY AND THE PERICARDIUM HAD BEEN PUNCTURED. THE PHYSICIAN REPORTED THAT A PIECE OF CALCIFIED PLAQUE MAY HAVE CAUSED THE PERFORATION FOLLOWING THE STENT DEPLOYMENT, WHICH RESULTED IN AN INCREASED PRESSURE ON THE ALREADY THIN ARTERY WALLS. A 2.00X30MM EMERGE BALLOON CATHETER AND A NON-BSC GRAFT STENT WERE ADVANCED IN ATTEMPT TO TREAT THE PERFORATION, HOWEVER THE BLOOD FLOW THROUGH THE PERFORATION COULD NOT BE STOPPED. AFTER 45 MINUTES OF REANIMATION EFFORTS THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT; "ADDITIONAL PREDILATION WAS PERFORMED WITH A 2.00X30MM EMERGE BALLOON CATHETER TO 16 ATMOSPHERES FOR 10 SECONDS." HOWEVER, THE 2.00X30MM EMERGE BALLOON CATHETER WAS NOT USED FOR PRE-DILATION AND WAS ONLY USED DURING THE ATTEMPTS TO TREAT THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416220 0015496421

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death