BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 23328328 · Received October 17, 2025

    Report

    Report Number
    2124215-2025-73303
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729579656
    PMA / PMN Number
    K133110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 09/01/2025 AS THE EXACT EVENT DATE WAS NOT REPORTED. G4 - PREMARKET / 510(K): K133110, P090003.

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 09/01/2025 AS THE EXACT EVENT DATE WAS NOT REPORTED. G4 - PREMARKET / 510(K): K133110, P090003.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED COMPLICATIONS POST STENT IMPLANTATION. ON THE (B)(6) 2023, A 6.0X30X75CM EXPRESS LD STENT WAS IMPLANTED IN THE RENAL ARTERY AND A CLOSURE DEVICE WAS USED ON THEIR ILIAC DURING AN ANEURYSM REPAIR COMPLICATION. SINCE THEN, THE PATIENT NEVER HAD A FOLLOW UP VISIT (SUCH AS MAGNETIC RESONANCE ANGIOGRAPH (MRA) OR COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA)). FOR OVER A YEAR, THE PATIENT HAD A BURNING SENSATION IN THEIR COCCYX AREA, FECAL INCONTINENCE, URINE INCONTINENCE, NUMBNESS IN THEIR RIGHT LEG AFTER WALKING A RELATIVELY SHORT DISTANCE THAT WOULD GET BETTER WITH REST, DIFFICULTY STANDING UP AFTER SITTING FOR A WHILE, THIRST, AND THE KIDNEYS INFARCTED TO THE POINT OF FALLING TO CHRONIC KIDNEY DISEASE (CKD) STAGE 3, A GLOMERULAR FILTRATION RATE (GFR) OF 50 THAT WAS THE LOWEST REGISTERED, AND HIGH BLOOD PRESSURE. THE PATIENT ALSO DEVELOPED POST-TRAUMATIC STRESS DISORDER (PTSD) BELIEVED TO BE BECAUSE THE PROCEDURE WAS PERFORMED WITHOUT ANESTHESIA. THE ONLY FOLLOW-UP THE PATIENT RECEIVED WAS A NON-CONTRAST COMPUTED TOMOGRAPHY (CT) SCAN THAT SHOWED THE STENT STILL IMPLANTED, AND A DOPPLER TEST TO CHECK ON THE FEMORAL AND EXTERNAL ILIAC ARTERY. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE STENT WAS PLACED AND CLOSURE DEVICE BY THE PHYSICIAN. ON (B)(6) 2023, THE PATIENT WENT TO THE HEALTH FACILITY, AND A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED. 32 MONTH5 LATER, THE PATIENT WENT TO HAVE A FOLLOW UP CHECK AND WAS DENIED, AND THE PATIENT SYMPTOMS WAS NOT ADDRESSED. THE PATIENT WAS DISCHARGED AND WAS TOLD NO FURTHER APPOINTMENT NEEDED. THE PATIENT HAS TROUBLE WITH THE BLADDER, CRAMPS IN THE RIGHT BUTT, NUMBNESS IN RIGHT LEG AFTER WALKING SOME DISTANCE, CASUAL FECAL INCONTINENCE, AND A FALL THAT REQUIRED 6 STITCHES IN MY RIGHT LEG THAT TOOK ONE YEAR TO HEAL AND THE PATIENT IS NOT DIABETIC. ALSO, THE PATIENT HAS DEVELOPED HIGH BLOOD PRESSURE AND SOMETIMES HAS DIFFICULTY IN WALKING. THE PATIENT UNDERGOES TREATMENT FOR CHRONIC POST-TRAUMATIC STRESS DISORDER (PTSD) CAUSED BY THIS PROCEDURE BEING PERFORMED WITHOUT ANESTHESIA. THE PATIENT ALSO STATES THAT DURING THE ANEURYSM PROCEDURE, THERE WAS LACKING IN THE NEEDED EQUIPMENT AND HAD TO WAIT ABOUT AN HOUR FOR A STENT AND CLOSURE DEVICE. BY THE TIME THEY ARRIVED, THE ANESTHESIA HAD WORN OFF, BUT THE PROCEDURE CONTINUED WITHOUT ADDRESSING THIS. THE ANEURYSM WAS LOCATED AT THE AORTA ARTERY AT THE ENTRANCE OF THE RIGHT KIDNEY RIGHT IN THE INTERSECTION WITH THE ILIAC ARTERY. PRIOR TO PROCEDURE, THE PATIENT WAS COMPLAINING ABOUT BEING BLOATED AFTER EATING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED COMPLICATIONS POST STENT IMPLANTATION. ON THE (B)(6) 2023, A 6.0X30X75CM EXPRESS LD STENT WAS IMPLANTED IN THE RENAL ARTERY AND A CLOSURE DEVICE WAS USED ON THEIR ILIAC DURING AN ANEURYSM REPAIR COMPLICATION. SINCE THEN, THE PATIENT NEVER HAD A FOLLOW UP VISIT (SUCH AS MAGNETIC RESONANCE ANGIOGRAPH (MRA) OR COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA)). FOR OVER A YEAR, THE PATIENT HAD A BURNING SENSATION IN THEIR COCCYX AREA, FECAL INCONTINENCE, URINE INCONTINENCE, NUMBNESS IN THEIR RIGHT LEG AFTER WALKING A RELATIVELY SHORT DISTANCE THAT WOULD GET BETTER WITH REST, DIFFICULTY STANDING UP AFTER SITTING FOR A WHILE, THIRST, AND THE KIDNEYS INFARCTED TO THE POINT OF FALLING TO CHRONIC KIDNEY DISEASE (CKD) STAGE 3, A GLOMERULAR FILTRATION RATE (GFR) OF 50 THAT WAS THE LOWEST REGISTERED, AND HIGH BLOOD PRESSURE. THE PATIENT ALSO DEVELOPED POST-TRAUMATIC STRESS DISORDER (PTSD) BELIEVED TO BE BECAUSE THE PROCEDURE WAS PERFORMED WITHOUT ANESTHESIA. THE ONLY FOLLOW-UP THE PATIENT RECEIVED WAS A NON-CONTRAST COMPUTED TOMOGRAPHY (CT) SCAN THAT SHOWED THE STENT STILL IMPLANTED, AND A DOPPLER TEST TO CHECK ON THE FEMORAL AND EXTERNAL ILIAC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492648 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938046630750 0030564020 08714729579656

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown Other