BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS SR PRO2

    MDR report key: 1442610 · Received August 13, 2009

    Report

    Report Number
    2939204-2009-00667
    Event Type
    Injury
    Date Received
    August 13, 2009
    Date of Event
    July 17, 2009
    Report Date
    July 17, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING USE OF AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER IN A PERCUTANEOUS CORONARY INTERVENTION (PCI), TIP DETACHMENT OCCURRED. A STENT HAD BEEN PREVIOUSLY IMPLANTED IN THE PROXIMAL AREA OF RIGHT CORONARY ARTERY (RCA). THE DISTAL PORTION OF THE UNK STENT WAS 90% RE-STENOSED WITH A CALCIFICATION AND MODERATELY TORTUOUS. ACCESS TO THE LESION WAS ACHIEVED BY FEMORAL APPROACH. PRE-IVUS WAS COMPLETED WITHOUT ANY DIFFICULTIES. A NEW STENT WAS DEPLOYED IN THE IN-STENT RESTENOSED (ISR) LESION; HOWEVER, THE STENT DID NOT ADHERE TIGHTLY TO THE VESSEL WALL AN "INDENTATION" REMAINED IN PART OF THE STENT. THE PHYSICIAN ATTEMPTED POST-IVUS WITH THE IMAGING CATHETER, BUT THE CATHETER BUMPED ONTO THE NEWLY-IMPLANTED STENT IMPEDING THE IVUS CATHETER FROM CROSSING THE LESION. WHILE WITHDRAWING (PULLING) THE CATHETER THE PHYSICIAN FELT MILD RESISTANCE; FLUOROSCOPY WAS USED TO VERIFY THE ANOMALY BUT HE WAS UNABLE TO CONFIRM IF THE CATHETER HAD CAUGHT THE STENT. THE PHYSICIAN WAS ABLE TO REMOVE THE IMAGING CATHETER SUCCESSFULLY FROM THE PT WHEN HE DISCOVERED APPROXIMATELY 15 MM OF IVUS DISTAL TIP WAS MISSING. THE DETACHED TIP WAS LOCATED INSIDE THE INTRODUCER SHEATH. IN THE PROCESS OF WITHDRAWING THE INTRODUCER SHEATH FROM THE PT THE DETACHED TIP MIGRATED INTO THE DISTAL PORTION OF THE PT'S LEG. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED WITH A SNARE DEVICE AND REMOVED FROM THE PT'S ANATOMY. THE PT WAS REPORTED TO BE IN "GOOD" CONDITION. REFERENCE MFR REPORT # 2134265-2009-03845 ON THE ISR STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS SR PRO2 CORONARY IMAGING CATHETER DQO BOSTON SCIENTIFIC CORPORATION H749390140 12668014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SIZE UNK INTRODUCER SHEATH| ENDEAVOR STENT| MEDTRONIC