BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS (TM) LD VASCULAR

    MDR report key: 2093484 · Received May 18, 2011

    Report

    Report Number
    2134265-2011-01988
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL AND TACTILE EXAMINATION OF THE DEVICE REVEALED NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. THE STENT WAS STILL ON THE BALLOON HOWEVER IT WAS NOTED THAT THE STENT HAD MOVED 2MM DISTALLY TOWARDS THE TIP OF THE DEVICE. THE PROXIMAL SECTION OF THE BALLOON WAS FOLDED AND A CLEAR IMPRESSION OF WHERE THE STENT WAS ORIGINALLY CRIMPED WAS VISIBLE ON THE BALLOON MATERIAL. VISUAL EXAMINATION OF THE STENT NOTED THAT SOME OF THE STRUTS BETWEEN ROWS 10 AND 19 PROXIMAL TO THE EDGE OF THE DISTAL STENT WERE MISALIGNED AND SOME OF THE STRUTS WERE LIFTED UP. ONE OF THE STRUTS ON THE DISTAL END OF THE STENT HAD BEEN LIFTED UP AND SOME WERE MISALIGNED. FROM THE CONDITION OF THE STENT AND THE BALLOON IT WAS NOT POSSIBLE TO CHECK THE PROFILE MEASUREMENTS. THE DEVICE WAS PASSED OVER A 0.035" GUIDEWIRE WITH NO RESTRICTIONS NOTED. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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 PERCUTANEOUS CORONARY INTERVENTION PROCEDURE STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. A 8.0X60X135 CM EXPRESS VASCULAR LD STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RIGHT COMMON ILIAC ARTERY. HOWEVER DURING ADVANCEMENT SOME FRICTION WAS ENCOUNTERED AT THE ILIAC BIFURCATION. DAMAGE WAS NOTED ON THE STENT DELIVERY SYSTEM. THE EXPRESS VASCULAR SDS WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT LESION WAS DENOVO AND 70% STENOSED. THE DEGREE OF TORTUOUSITY WAS A LITTLE SEVERE WITH SEVERE CALCIFICATION. THE STENT DELIVERY SYSTEM (SDS) WAS NOT ADVANCED THROUGH A PREVIOUSLY PLACED STENT. A STRUT OF THE STENT WAS DAMAGED WHEN THE SDS WAS ADVANCED OVER THE WIRE AND THROUGH THE ILIAC BIFURCATION. THE STENT REMAINED ATTACHED TO THE SDS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT LESION WAS DENOVO AND 70% STENOSED. THE DEGREE OF TORTUOUSITY WAS A LITTLE SEVERE WITH SEVERE CALCIFICATION. THE STENT DELIVERY SYSTEM (SDS) WAS NOT ADVANCED THROUGH A PREVIOUSLY PLACED STENT. A STRUT OF THE STENT WAS DAMAGED WHEN THE SDS WAS ADVANCED OVER THE WIRE AND THROUGH THE ILIAC BIFURCATION. THE STENT REMAINED ATTACHED TO THE SDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS (TM) LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162860130 13883798

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR