BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS? VASCULAR SD

    MDR report key: 3120632 · Received May 20, 2013

    Report

    Report Number
    2134265-2013-03514
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED FIELDS: DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES DEVICE EVALUATED BY MFR.: DEVICE WAS RETURNED, CONSISTED OF AN EXPRESS SD STENT DELIVERY SYSTEM (SDS) WITH STENT AND NO ORIGINAL PACKAGING OR OTHER DEVICES. THE STENT WAS RECEIVED DETACHED/SEPARATED FROM THE SDS. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BETWEEN THE STENT STRUTS. THERE WAS BLOOD IN THE GUIDEWIRE LUMEN AND IN BETWEEN THE BALLOON FOLDS. THE BALLOON WAS TIGHTLY FOLDED WITH STENT IMPRESSIONS ON THE SURFACE OF THE BALLOON BETWEEN THE MARKERBANDS. THE STENT WAS DAMAGED WITH ONE ROW OF STRUTS BENT AND FLARED. INSPECTION OF THE REMAINDER OF THE DEVICE AND STENT PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT OR THE CONFIRMED DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT EMBOLISM OCCURRED. THE 80% STENOSED LESION WAS LOCATED AT THE SUPERIOR MESENTERIC ARTERY (SMA). A 7.0 MM X 19 MM X 90 CM EXPRESS VASCULAR EXPRESS SD STENT WAS USED TO TREAT THE LESION VIA THE FEMORAL ARTERY WITH A 135 DEGREE ANGLE. A MACH 1 GUIDE CATHETER WAS PLACED NEAR THE OSTIUM OF THE SMA AND A V18 GUIDEWIRE WAS USED, WHILE ATTEMPTING TO PASS THE ARTERY THE MACH 1 GUIDE CATHETER WAS OBSERVED BEING PUSHED OUT, AND THE BODY OF THE WIRE WAS MOVING UP THE AORTA RATHER THAN THE SMA. V18 WAS REPLACED BY A V14 GUIDEWIRE AND SUCCESSFULLY CROSSED THE LESION. THE 7.0 MM X 19 MM X 90 CM EXPRESS VASCULAR EXPRESS SD STENT WAS PASSED OVER THE WIRE BUT AS IT NEARED THE TIP OF V14 THE GUIDE CATHETER IT WAS BEING STRAIGHTENED AND THE MACH 1 GUIDEWIRE WAS BEING PULLED OUT OF THE SMA. A WIRE EXCHANGED WAS SUCCESSFULLY DONE USING A MICROCATHETER AND V14 WAS REPLACED BY V18. THE MICROCATHETER WAS REMOVED AND THE 7.0 MM X 19 MM X 90 CM EXPRESS VASCULAR EXPRESS SD STENT WAS REINTRODUCED, AS IT ATTEMPTED TO PASS THE SMA RESISTANCE WAS FELT SO THE STENT WAS ATTEMPTED TO PULL BACK TO REPOSITION THE GUIDE CATHETER AND NOTICED THE STENT PARTIALLY DETACHED FROM THE BALLOON BEING HELD 1/3 BY THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS WITHDRAWN BUT IT WAS IMPOSSIBLE SO THEY INCLUDED TO REMOVE THE MACH 1 GUIDE CATHETER UP TO THE INTRODUCER SHEATH. THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED BUT THE STENT BECAME TOTALLY DETACHED FROM THE DELIVERY SYSTEM WHICH WAS ALSO REMOVED. THE 7.0 MM X 19 MM X 90 CM EXPRESS VASCULAREXPRESS SD STENT WAS SITTING OUTSIDE THE INTRODUCER SHEATH WITH A GUIDEWIRE RUNNING THROUGH WAS SNARED AND BOTH WERE SUCCESSFULLY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT EMBOLISM OCCURRED. THE 80% STENOSED LESION WAS LOCATED AT THE SUPERIOR MESENTERIC ARTERY (SMA). A 7.0MMX19MMX90CM EXPRESS VASCULAR EXPRESS SD STENT WAS USED TO TREAT THE LESION VIA THE FEMORAL ARTERY WITH A 135 DEGREE ANGLE. A MACH 1 GUIDE CATHETER WAS PLACED NEAR THE OSTIUM OF THE SMA AND A V18 GUIDEWIRE WAS USED, WHILE ATTEMPTING TO PASS THE ARTERY THE MACH 1 GUIDE CATHETER WAS OBSERVED BEING PUSHED OUT, AND THE BODY OF THE WIRE WAS MOVING UP THE AORTA RATHER THAN THE SMA. V18 WAS REPLACED BY A V14 GUIDEWIRE AND SUCCESSFULLY CROSSED THE LESION. THE 7.0MMX19MMX90CM EXPRESS VASCULAR EXPRESS SD STENT WAS PASSED OVER THE WIRE BUT AS IT NEARED THE TIP OF V14 THE GUIDE CATHETER IT WAS BEING STRAIGHTENED AND THE MACH 1 GUIDEWIRE WAS BEING PULLED OUT OF THE SMA. A WIRE EXCHANGED WAS SUCCESSFULLY DONE USING A MICROCATHETER AND V14 WAS REPLACED BY V18. THE MICROCATHETER WAS REMOVED AND THE 7.0MMX19MMX90CM EXPRESS VASCULAR EXPRESS SD STENT WAS REINTRODUCED, AS IT ATTEMPTED TO PASS THE SMA RESISTANCE WAS FELT SO THE STENT WAS ATTEMPTED TO PULL BACK TO REPOSITION THE GUIDE CATHETER AND NOTICED THE STENT PARTIALLY DETACHED FROM THE BALLOON BEING HELD 1/3 BY THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS WITHDRAWN BUT IT WAS IMPOSSIBLE SO THEY INCLUDED TO REMOVE THE MACH 1 GUIDE CATHETER UP TO THE INTRODUCER SHEATH. THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED BUT THE STENT BECAME TOTALLY DETACHED FROM THE DELIVERY SYSTEM WHICH WAS ALSO REMOVED. THE 7.0MMX19MMX90CM EXPRESS VASCULAREXPRESS SD STENT WAS SITTING OUTSIDE THE INTRODUCER SHEATH WITH A GUIDEWIRE RUNNING THROUGH WAS SNARED AND BOTH WERE SUCCESSFULLY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222190 EXPRESS? VASCULAR SD CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937918719900 15064618

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention