MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	H74938046630750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Burning Sensation (2146); Numbness (2415); Renal Impairment (4499); Fecal Incontinence (4571); Urinary Incontinence (4572)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23328328
• Report Number: 2124215-2025-73303
• Device Sequence Number: 21319326
• Product Code: NIO
• UDI-Device Identifier: 08714729579656
• UDI-Public: (01)08714729579656(17)251117(10)30564020
• Combination Product (Y/N): N
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2025
• Device Model Number: H74938046630750
• Device Catalogue Number: H74938046630750
• Device Lot Number: 0030564020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/13/2025
• Date Device Manufactured: 11/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Unknown