BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS? SR PRO²

    MDR report key: 3033776 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-02210
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE EVALUATED BY MANUFACTURER, EVALUATION SUMMARY ATTACHED, METHOD CODES, RESULT CODES,CONCLUSION CODES. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE SECTION OF THE SHEATH COMPRISING OF THE DISTAL SHAFT SEPARATED FROM THE MIDSHAFT AND WAS NOT RETURNED. KINKS WERE OBSERVED IN THE SHEATH ASSEMBLY AT 3.8CM AND 10.2CM FROM FEMORAL MARKER AT THE DISTAL END. THE EDGE OF THE MIDSHAFT AT POINT OF BREAKAGE APPEARED TO BE STRETCHED. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS OF THE RETURNED DEVICE. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER RELATED AS THE DFU STATES "INADEQUATELY APPOSED STENTS, OVERLAPPING STENTS, AND/OR SMALL STENTED VESSELS WITH DISTAL ANGULATION MAY LEAD TO ENTRAPMENT OF THE CATHETER WITH THE STENT UPON RETRACTION.¿ THE COMPLAINT REPORTS THE STENTS WERE OVERLAPPED AND THE OVERLAPPING AREA WAS NOT WELL DILATED. (B)(4).

    Description of Event or Problem · 1

    SAME AS MDR ID 2134265-2013-02630. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, AN IMAGING CATHETER GOT DETACHED AND WAS STUCK IN STENT. THE LESION WAS 90% STENOSED, OVER 42MM LONG, WITH A PROXIMAL INNER DIAMETER OF 3.5MM AND DISTAL INNER DIAMETER OF 2.25MM, WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) ARTERY. PREDILATION OF THE TARGET LESION WAS DONE USING AN UNSPECIFIED BALLOON CATHETER. A 2.25MM X 28MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS THEN SELECTED AND ADVANCED TO TREAT THE TARGET LESION AND WAS INFLATED 3 TIMES AT 12 ATMS. A NON-BSC STENT WAS ALSO SELECTED AND ADVANCED TO TREAT THE TARGET LESION AND WAS INFLATED THREE TIMES AT 8 ATM. IT WAS NOTED THAT THE NON-BSC STENT AND THE PROMUS ELEMENT PLUS STENT WERE NOT WELL APPOSED. THE OVERLAPPED AREA WAS NOT DILATED WELL. AN ATLANTIS SR PRO IMAGING CATHETER WAS THEN SELECTED AND ADVANCED TO THE TARGET LESION FOR INTRAVASCULAR ULTRASOUND. NO ISSUE WAS NOTED ON THE FIRST PULLBACK. DURING THE NEXT MANUAL PULLBACK IT WAS NOTED THAT THE ATLANTIS CATHETER GOT STUCK TO THE DISTAL EDGE OF THE NON-BSC STENT. THE PHYSICIAN MOVED THE IMAGING CATHETER FORWARD; HOWEVER, IT WAS NOTED THAT THE ATLANTIS IMAGING CATHETER WAS UNABLE TO MOVE. THE ATLANTIS IMAGING CATHETER WAS WITHDRAWN. UPON REMOVAL, IT WAS NOTED THAT NON-BSC GUIDE CATHETER WAS ALSO REMOVED TOGETHER WITH THE ATLANTIS IMAGING CATHETER. IT WAS ALSO NOTED THAT APPROXIMATELY 20 CM FROM THE TIP OF THE IMAGING CATHETER REMAINED INSIDE THE PATIENT. IT WAS ALSO OBSERVED THAT THE MARKER OF THE IMAGING CATHETER WAS AT THE MIDDLE OF THE PROXIMAL LCX. IT WAS THEN NOTED THAT THE PATIENT'S BLOOD PRESSURE DECREASED AND WAS TREATED WITH MEDICATIONS RESULTING IN A SLIGHT IMPROVEMENT. THE PHYSICIAN WAS UNABLE TO RE-WIRE THE LCX. THE PATIENT WAS STABILIZED. LATER THAT NIGHT THE PATIENT UNDERWENT SURGERY IN A DIFFERENT HOSPITAL WHERE THEY RETRIEVED THE NON-BSC STENT, THE PROMUS ELEMENT PLUS STENT AND THE DETACHED IMAGING CATHETER COMPONENT. A CABG WAS PERFORMED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME AS MDR ID 2134265-2013-02630. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, AN IMAGING CATHETER GOT DETACHED AND WAS STUCK IN STENT. THE LESION WAS 90% STENOSED, OVER 42MM LONG, WITH A PROXIMAL INNER DIAMETER OF 3.5MM AND DISTAL INNER DIAMETER OF 2.25MM, WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) ARTERY. PREDILATION OF THE TARGET LESION WAS DONE USING AN UNSPECIFIED BALLOON CATHETER. A 2.25MM X 28MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS THEN SELECTED AND ADVANCED TO TREAT THE TARGET LESION AND WAS INFLATED 3 TIMES AT 12 ATMS. A NON-BSC STENT WAS ALSO SELECTED AND ADVANCED TO TREAT THE TARGET LESION AND WAS INFLATED THREE TIMES AT 8 ATM. IT WAS NOTED THAT THE NON-BSC STENT AND THE PROMUS ELEMENT PLUS STENT WERE NOT WELL APPOSED. THE OVERLAPPED AREA WAS NOT DILATED WELL. AN ATLANTIS SR PRO IMAGING CATHETER WAS THEN SELECTED AND ADVANCED TO THE TARGET LESION FOR INTRAVASCULAR ULTRASOUND. NO ISSUE WAS NOTED ON THE FIRST PULLBACK. DURING THE NEXT MANUAL PULLBACK IT WAS NOTED THAT THE ATLANTIS CATHETER GOT STUCK TO THE DISTAL EDGE OF THE NON-BSC STENT. THE PHYSICIAN MOVED THE IMAGING CATHETER FORWARD; HOWEVER, IT WAS NOTED THAT THE ATLANTIS IMAGING CATHETER WAS UNABLE TO MOVE. THE ATLANTIS IMAGING CATHETER WAS WITHDRAWN. UPON REMOVAL, IT WAS NOTED THAT NON-BSC GUIDE CATHETER WAS ALSO REMOVED TOGETHER WITH THE ATLANTIS IMAGING CATHETER. IT WAS ALSO NOTED THAT APPROXIMATELY 20 CM FROM THE TIP OF THE IMAGING CATHETER REMAINED INSIDE THE PATIENT. IT WAS ALSO OBSERVED THAT THE MARKER OF THE IMAGING CATHETER WAS AT THE MIDDLE OF THE PROXIMAL LCX. IT WAS THEN NOTED THAT THE PATIENT¿S BLOOD PRESSURE DECREASED AND WAS TREATED WITH MEDICATIONS RESULTING IN A SLIGHT IMPROVEMENT. THE PHYSICIAN WAS UNABLE TO RE-WIRE THE LCX. THE PATIENT WAS STABILIZED. LATER THAT NIGHT THE PATIENT UNDERWENT SURGERY IN A DIFFERENT HOSPITAL WHERE THEY RETRIEVED THE NON-BSC STENT, THE PROMUS ELEMENT PLUS STENT AND THE DETACHED IMAGING CATHETER COMPONENT. A CABG WAS PERFORMED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136427 ATLANTIS? SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 15715499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTRODUCER SHEATH: ORCUS, 6FR/TERUMOT| BALLOON CATHETER: IKADUCHI/2.0MM-15MM/KANEKA| GUIDE WIRE: GRANDSLAM /ASAHI| TENT: NOBORI| GUIDING CATHETER: TAIGA/6FR-JL4SH/MD| INFLATION DEVICE: EVEREST