BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1842934 · Received September 23, 2010

    Report

    Report Number
    2134265-2010-04473
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    May 19, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT.(B)(4).DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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

    DESCRIBE EVENT OR PROBLEM - A 4.0X12MM PROMUS ELEMENT STENT WAS CORRECTED FROM A NO CROSS EVENT TO A STENT DISLODGEMENT, A 4.0X28MM PROMUS ELEMENT STENT WAS CORRECTED FROM A DISLODGEMENT TO BEING DEPLOYED. IF IMPLANTED, GIVE DATE - ADDITIONAL INFORMATION, (B)(4) 2010. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT#: 2134265-2010-04558. IT WAS INITIALLY REPORTED THAT A 4.0X12MM PROMUS ELEMENT STENT WAS ADVANCED IN AN ATTEMPT TO TREAT A DISSECTION, BUT COULD NOT CROSS THE LESION. IT WAS ALSO INITIALLY REPORTED THAT A 4.0X28MM PROMUS ELEMENT STENT WAS ADVANCED IN AN ATTEMPT TO TREAT THE DISSECTION, BUT THE STENT DISLODGED AND EMBOLIZED TO THE AORTA. THIS HAS BEEN CORRECTED TO: A 4.0X12MM PROMUS ELEMENT STENT WAS ADVANCED IN AN ATTEMPT TO TREAT A DISSECTION, BUT COULD NOT CROSS THE LESION. UPON WITHDRAWAL OF THE DEVICE, THE STENT DISLODGED AND EMBOLIZED TO THE AORTA. A 4.0X28MM PROMUS ELEMENT STENT WAS ADVANCED IN AN ATTEMPT TO TREAT THE DISSECTION AND WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY OVERLAPPING 3.5X24MM AND 3.0X12MM PROMUS ELEMENT STENTS.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-04476, 2134265-2010-04477. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH STABLE ANGINA PECTORIS. ANGIOGRAPHY REVEALED SIGNIFICANT ONE VESSEL DISEASE. THE GREATER THAN 50% STENOSED LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A PT GRAPHIX INTERMEDIATE GUIDE WIRE WAS PLACED IN THE LESION. A 2.0X15MM MAVERICK BALLOON WAS ADVANCED TO THE LESION TO PREDILATE AND INFLATED TO 14 AND 16 ATMS. A 3.5X24MM PROMUS ELEMENT STENT WAS ADVANCED TO THE LESION AND DEPLOYED AT 18 ATMS. A 3.0X12MM PROMUS ELEMENT STENT WAS ADVANCED TO THE LESION AND DEPLOYED AT 14 ATMS OVERLAPPING THE PRIOR PLACED STENT. A 4.0X15MM QUANTUM MAVERICK BALLOON WAS ADVANCED TO THE LESION AND WAS INFLATED TO 8, 12 AND 15 ATMS FOR POSTDILATION. AFTER THE PLACEMENT OF THE STENTS AND POSTDILATION A DISSECTION IN THE PROXIMAL LAD IS WAS NOTED VIA ANGIOGRAPHY. A 4.0X12MM PROMUS STENT WAS ADVANCED IN AN ATTEMPT TO TREAT THE DISSECTION, BUT COULD NOT CROSS THE LESION. THE LESION WAS AGAIN DILATED WITH BOTH A 2.0X12MM MAVERICK AND A 2.0X20MM MAVERICK BALLOON. A 4.0X28MM PROMUS ELEMENT STENT WAS ADVANCED IN AN ATTEMPT TO TREAT THE DISSECTION, BUT THE STENT DISLODGED AND EMBOLIZED TO THE AORTA WITH THE PROXIMAL SECTION IN THE LEFT MAIN ARTERY. A 4.0X16MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE PROXIMAL TO MID LAD. A 4.0X20MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE LEFT MAIN TO JAIL THE DISTAL END OF THE DISLODGED STENT. THE 4.0X20MM PROMUS ELEMENT STENT WAS NOTED TO BE MALAPPOSED VIA IVUS AND WAS POST-DILATED WITH 1.5X15MM AND 2.0X15 MM MAVERICK BALLOONS AS WELL AS A 5.0X15MM QUANTUM MAVERICK BALLOON. THIS RESULTED IN GOOD POSITIONING AND APPOSITION. THE PROCEDURE WAS COMPLETED AT THIS TIME. NO FURTHER PATIENT COMPLICATIONS OCCURRED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE CASE AND REMAINS STABLE. THE PATIENT REMAINED IN THE HOSPITAL OVERNIGHT FOR MONITORING AND HAS BEEN DISCHARGED ON ASPIRIN, CLOPIDOGREL, BETA-BLOCKERS AND AN ACE INHIBITOR. 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 H7493911328400 13171274

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention 2.0X15MM MAVERICK BALLOON| 2.0X12MM MAVERICK BALLOON| (4) PT GRAPHIX INTERMEDIATE GUIDE WIRE| 3.5X24MM PROMUS ELEMENT STENT| 3.0X12MM PROMUS ELEMENT STENT| 4.0X15MM QUANTUM MAVERICK BALLOON| 4.0X12MM PROMUS ELEMENT STENT| 2.0X20MM MAVERICK BALLOON