BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2062902 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01172
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS AND STENT DAMAGE OCCURRED. IN (B)(6) 2010, A 2.25 X 24MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE IN LEFT ANTERIOR DESCENDING (LAD) ARTERY. IN MARCH 2011, THE PATIENT PRESENTED WITH 'REOCCURRING SYMPTOMS'. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. IN-STENT RESTENOSIS WAS IDENTIFIED IN THE PREVIOUSLY PLACED 2.25X24MM PROMUS ELEMENT STENT. THE 60% RESTENOSED, APPROXIMATELY 5MM, CONCENTRIC, FOCAL LESION WAS LOCATED IN THE PROXIMAL PORTION OF THE STENT. THE LESION WAS PREDILATED WITH A 3.0X8MM QUANTUM MAVERICK BALLOON. FOLLOWING THE DILATION, THE PHYSICIAN FOUND THE DISTAL EDGE OF THE PROMUS ELEMENT STENT HAD BECOME 'DEFORMED AND WRINKLED'. THE PHYSICIAN ATTEMPTED TO USE A 3.0X15MM NON-BSC STENT TO REPAIR THE STENT DAMAGE, BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED BY USING A 3.0X33MM NON-BSC STENT TO COVER THE TOTAL LENGTH OF THE PROMUS ELEMENT STENT. THEN A 3.0X 20MM QUANTUM MAVERICK BALLOON WAS USED TO POST DILATE, WITH GOOD ANGIOGRAPHIC RESULT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324250 13579128

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention