BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G ATLANTIS SR PRO TO THE SECOND POWER

    MDR report key: 1063131 · Received June 20, 2008

    Report

    Report Number
    2939204-2008-00235
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN QUESTION WILL NOT BE PROVIDED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS DUE TO DISPOSAL. ATTEMPTS TO OBTAIN THE LOT NUMBER HAVE BEEN MADE; HOWEVER, ADDITIONAL INFORMATION COULD NOT BE OBTAINED. DUE TO LACK OF LOT NUMBER, THE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN IMAGING CATHETER BECAME STUCK WITH A STENT. THE LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX) ARTERY. TORTUOSITY, PERCENT STENOSIS, AND CALCIFICATION OF THE LESION ARE UNKNOWN. THE MID-LCX WAS DILATED THREE TIMES WITH A BALLOON CATHETER. AFTER PRE-DILATION THE LESION WAS CONFIRMED WITH AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER. A STENT WAS DEPLOYED FROM DISTAL TO MID LCX, FOLLOWED BY IVUS. A SECOND STENT WAS DEPLOYED FROM MID TO PROXIMAL LCX, AGAIN FOLLOWED BY IVUS. AFTER COMPLETION OF THE IMAGING RUN, PHYSICIAN TRIED TO REMOVE THE IVUS IMAGING CATHETER; HOWEVER, THE IMAGING CATHETER HAD BECOME STUCK AT THE DISTAL EDGE OF THE FIRST DEPLOYED STENT. THE PHYSICIAN MADE AN UNSUCCESSFUL ATTEMPT TO RELEASE THE CATHETER. THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL TO HAVE THE DEVICE SURGICALLY REMOVED. DURING SURGICAL PROCEDURE, THE AORTA WAS INCISED IN AN ATTEMPT TO RELEASE THE DEVICE, HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL; THEREFORE, THE DEVICE WAS CUT OFF AT THE SHAFT AND DEVICE REMAINS IN THE PATIENT'S AORTA. AORTA-CORONARY (A-C) BYPASS WAS PERFORMED FROM AORTA TO POSTEROLATERAL BRANCH. THE PATIENT REMAINS HOSPITALIZED AND HIS CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F/G ATLANTIS SR PRO TO THE SECOND POWER CORONARY IMAGING CATHETER DQO BOSTON SCIENTIFIC CORP. 39014 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R (1ST) MEDTRONIC - DRIVER STENT| TERUMO CORP - RYUJIN PLUS BALLOON CATHETER| (2ND) ABBOTT VASCULAR - ZETA STENT