BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

    MDR report key: 2003503 · Received March 1, 2011

    Report

    Report Number
    2134265-2011-00407
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER. THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, WITHDRAWAL DIFFICULTIES AND A STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED IN A RETROGRADE APPROACH VIA THE LEFT FEMORAL ARTERY USING ANOTHER MANUFACTURERS' 7F 10CM INTRODUCER SHEATH. THE DIFFUSED TARGET LESION WAS 80% STENOSED, 15CM LONG AND LOCATED IN THE MODERATELY CALCIFIED LEFT ILIAC ARTERY. THE LESION WAS NOT PRE-DILATED. ANOTHER MANUFACTURERS' 0.035" 180CM GUIDE WIRE WAS INSERTED AND A 7X57MM EXPRESS LD STENT WAS IMPLANTED IN THE DISTAL LEFT EXTERNAL ILIAC ARTERY. NEXT, A 9X57MM EXPRESS LD STENT WAS IMPLANTED IN THE MID LEFT EXTERNAL ILIAC ARTERY. THE PHYSICIAN THEN WANTED TO IMPLANT THIS 9.0X60X75CM EXPRESS VASCULAR LD STENT IN THE LEFT COMMON ILIAC ARTERY. DURING ADVANCEMENT OF THE STENT DELIVERY SYSTEM (SDS), THE TIP OF THE CATHETER WAS UNABLE TO PASS THROUGH THE PREVIOUSLY PLACED 9X57MM EXPRESS LD STENT IN THE MID LEFT EXTERNAL ILIAC ARTERY. AS A RESULT, THE PHYSICIAN CHOSE TO WITHDRAW THE SDS FROM THE PATIENT; HOWEVER, THE STENT BECAME STUCK AT THE DISTAL END OF THE INTRODUCER SHEATH CAUSING THE STENT TO DISLODGE FROM THE SDS. A 4F ANGIOGRAPHY CATHETER WAS INSERTED OVER THE 0.035" 180CM GUIDE WIRE. THAT GUIDE WIRE WAS THEN EXCHANGED TO A 200CM V-18 GUIDE WIRE AND A 6X40MM STERLING OTW BALLOON CATHETER WAS ADVANCED TO THE DISLODGED STENT. THE STERLING BALLOON CATHETER WAS USED TO DEPLOY THE STENT IN THE LEFT EXTERNAL ILIAC ARTERY. THE STENT WAS POST-DILATED WITH THE BALLOON FROM THE 7X57MM EXPRESS LD SDS. THE ANGIOGRAPHY CATHETER WAS USED AGAIN. THE V-18 GUIDE WIRE WAS EXCHANGED TO A 0.035" 180CM GUIDE WIRE AND THE INTRODUCER SHEATH WAS EXCHANGED TO ANOTHER MANUFACTURERS' 7F 25CM SHEATH. THE PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER 9.0X60X75CM EXPRESS VASCULAR LD STENT IN THE LEFT COMMON ILIAC ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THE PATIENT HAS SINCE BEEN DISCHARGED. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED U.S. DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162960750 0013471714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7F 10CM TERUMO INTRODUCER SHEATH| 7F 25CM MEDIKIT INTRODUCER SHEATH| 9X57MM EXPRESS LD STENT| 6X40MM STERLING OTW BALLOON CATHETER| 200CM V-18 GUIDE WIRE| 4F ANGIOGRAPHY CATHETER| ENCORE 26 INFLATION DEVICE| 0.035 180CM TERUMO GUIDE WIRE| 7X57MM EXPRESS LD STENT