BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPRESS BILIARY LD STENT SYSTEM

    MDR report key: 1581975 · Received January 13, 2010

    Report

    Report Number
    2134265-2010-00273
    Event Type
    Death
    Date Received
    January 13, 2010
    Date of Event
    December 4, 2009
    Report Date
    December 14, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K021630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2010-00274. IT WAS REPORTED THAT POST A STENTING PROCEDURE, A VESSEL RUPTURE OCCURRED. THE PT PRESENTED WITH SEVERE CLAUDICATION OF THE LEFT LEG. AN AORTAGRAM REVEALED THE LEFT EXTERNAL ILIAC ARTERY WAS COMPLETELY OCCLUDED FOR A LONG SEGMENT AND THE LEFT INTERNAL ILIAC ARTERY HAD APPROX 70% STENOSIS AT ITS TAKEOFF. AT THIS POINT, THE PHYSICIAN FELT THAT INTERVENTION OF THE LEFT ILIAC ARTERY WAS POSSIBLE. AN UNK 6FR SHEATH WAS PLACED IN THE LEFT COMMON FEMORAL ARTERY. AN UNK 6MM X 4CM BALLOON CATHETER WAS ADVANCED OVER AN ANGLED GLIDEWIRE AND THROUGH AN UNK ANGLED GUIDE CATHETER. THE LEFT EXTERNAL ILIAC ARTERY WAS BALLOONED TO APPROX 8-10 ATMOSPHERES IN THREE AREAS. AN ANGIOGRAPHY WAS COMPLETED AND REVEALED A PT LUMEN. THE 6FR SHEATH WAS EXCHANGED FOR A 7FR SHEATH. AN EXPRESS BILIARY LD 8 X 57 STENT WAS PLACED AT THE TAKEOFF OF THE LEFT EXTERNAL ILIAC ARTERY AND BALLOONED TO 8 ATMOSPHERES. AN EXPRESS BILIARY LD 7 X 57 STENT WAS THEN PLACED OVERLAPPING IN THE VESSEL AND BALLOONED TO 8 ATMOSPHERES. COMPLETION ANGIOGRAPHY WAS DONE BOTH ANTEGRADE AND RETROGRADE REVEALING EXCELLENT RESULTS WITH NO SIGNIFICANT STENOSIS NOTED IN THE LEFT ILIAC ARTERY. THE PT TOLERATED THE PROCEDURE WITHOUT DIFFICULTY. AFTER REMOVAL OF THE SHEATH, THE PT BECAME HYPOTENSIVE AND DEVELOPED LEFT LOWER QUADRANT PAIN. A FEMOSTOP WAS PLACED. THE PT WAS TAKEN FOR A STAT CT SCAN OF THE ABDOMEN, WHICH REVEALED A LARGE RETROPERITONEAL HEMORRHAGE. THE PT WAS TRANSFERRED TO THE OR FOR EMERGENCY SURGERY. EMERGENCY EXPLORATION OF THE LEFT GROIN REVEALED THE HEMORRHAGE WAS COMING FROM THE RUPTURED ARTERY IN THE EXTERNAL ILIAC WHERE THE STENTS HAD BEEN PLACED. THERE WAS A LARGE HEMATOMA. WHILE IN SURGERY, THE PT'S PRESSURE DROPPED PRECIPITOUSLY AND A MIDLINE ABDOMINAL INCISION WAS MADE. THERE WAS FREE BLOOD IN THE ABDOMINAL CAVITY WHICH WAS MOSTLY QUICKLY EVACUATED. SHORTLY THEREAFTER, THE PT DEVELOPED VENTRICULAR FIBRILLATION AND A MEDIAN STERNOTOMY WITH OPEN CARDIAC MASSAGE WAS REQUIRED. THE PT QUICKLY CAME BACK AFTER APPROX 2-3 MINS. THE PHYSICIANS REFOCUSED ON THE ABDOMEN WHERE THE ARTERY APPEARED TO HAVE MULTIPLE AREAS OF BLEEDING. THE COMMON ILIAC ARTERY WAS LIGATED WITH LARGE CLIPS AND A 3-0 PROLENE SUTURE LIGATURE. THE BLEEDING WAS THEN CONTROLLED, AND THE PT APPEARED TO BE HEMODYNAMICALLY MUCH MORE IMPROVED, ALTHOUGH HE WAS ON PRESSORS. THE PHYSICIANS REFOCUSED ON GETTING BLOCK BACK IN THE LEG. A FEMOROFEMORAL BYPASS WITH AN 8MM GORE-TEX GRAFT WAS COMPLETED. AFTERWARD, THERE APPEARED TO BE EXCELLENT FLOW WITH GOOD PULSE, INCLUDING THE FEET. THE PT HAD RECEIVED APPROX 8 UNITS OF BLOOD DURING THE PROCEDURE INCLUDING PLATELETS AND FRESH FROZEN PLASMA. THE TOTAL AMOUNT RECEIVED IS UNK AS THERE WAS BLOOD LOSS PRIOR TO ENTERING THE OR. THE INCISIONS WERE CLOSED AND THE PT APPEARED TO BE HEMODYNAMICALLY STABLE AT THIS POINT. THE PT LEFT THE OR IN CRITICAL CONDITION. IN 2009, AFTER DEVELOPING ACUTE RENAL FAILURE, A TEMPORARY DIALYSIS CATHETER WAS PLACED THROUGH THE RIGHT INTERNAL JUGULAR VEIN TO THE SUPERIOR VENA CAVA. THE PT TOLERATED THE PROCEDURE WELL AND WAS SUBSEQUENTLY TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE PT REMAINED IN ICU, WAS IN AND OUT OF ATRIAL FIBRILLATION AND CONTINUED RESPIRATORY AND RENAL FAILURE. FOUR DAYS LATER, A CT SCAN REVEALED CEREBROVASCULAR ACCIDENT WITH MULTIPLE EMBOLI AND ENCEPHALOPATHY. SIX DAYS LATER, THE PT WENT INTO CARDIAC ARREST AND ULTIMATELY EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H| L| O| R ANGLED GUIDE CATHETER| 6 FR SHEATH| ANGLED GLIDEWIRE| EXPRESS BILIARY LD STENT SYSTEM 7X57| 7 FR SHEATH| 6MM X 4 CM BALLOON CATHETER