BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3072930 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02626
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY A STENT DAMAGE POST DEPLOYMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. ANGIOGRAPHY REVEALED BLOCKAGE IN A MAJOR DIAGONAL ARTERY OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DE NOVO LESION STARTED AT THE OSTIUM OF THE MODERATELY TORTUOUS DIAGONAL ARTERY. THE LESION WAS PREDILATED. A 2.5 X 20MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE DIAGONAL ARTERY. DURING ANGIOGRAM JUST AFTER DEPLOYMENT, A FLAP WAS NOTICED IN THE LAD JUST PROXIMAL TO THE OSTIUM OF THE DIAGONAL ARTERY. THE PHYSICIAN DECIDED TO DEPLOY ANOTHER STENT TO COVER THE FLAP. A 3.5 X 20MM PROMUS ELEMENT MR STENT WAS PLACED IN POSITION IN THE LAD, COVERING THE OSTIUM OF THE DIAGONAL ARTERY. THE DEPLOYED STENT WAS WELL APPOSED. TO "MAKE A CLEAR PATHWAY" THE PHYSICIAN ATTEMPTED TO ADVANCE AN UNSPECIFIED NC BALLOON CATHETER THROUGH THE JAILED OSTIUM OF THE DIAGONAL ARTERY. AS THE BALLOON CATHETER WAS ADVANCED THROUGH THE DEPLOYED STENT IN THE LAD, THE PROXIMAL EDGE OF THE STENT WAS "HIT" AND THE STENT WAS DEFORMED. TO CORRECT THIS THE PHYSICIAN POST DILATED AGAIN BUT MORE DEFORMATION OCCURRED, SO SEVERELY THAT THE 20MM STENT LENGTH WAS REDUCED BY 5MM. AT THIS POINT THE PHYSICIAN DECIDED TO PERFORM NO FURTHER INTERVENTION BECAUSE THE STENT WAS STILL WELL APPOSED AND THE PROXIMAL EDGES WERE NOT "HANGING". NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173273 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320350 15346510

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention