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

Model Number	H74938046630750
Medical Device Problem Codes	Fracture (1260); Material Rupture (1546); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stents dislodged and required surgical intervention.The stenosed target lesion was located in the moderately tortuous and severely calcified superior mesenteric artery (sma).A 6.0x20x75cm express ld balloon expandable stent was selected for use.During the procedure, it was noted that the device did not track through the sma, and the balloon ruptured without being fully inflated.Subsequently, the stent fractured and dislodged from the balloon and got stuck in the sma then migrated down to the popliteal artery.The same issue occurred when another express ld balloon expandable stent was used.The physician attempted to snare the dislodged stents but was unsuccessful.As a result, an emergency cutdown was performed to successfully remove the stents, and the procedure was completed using a non-boston scientific (bsc) stent.The patient was admitted to the hospital beyond the standard of care but is expected to fully recover.
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k133110, p090003.Device eval by mfr: the device was not returned.However, a photo was provided from the healthcare facility, showing damage to the stent.
Event or Problem Description
It was reported that the stents dislodged and required surgical intervention.The stenosed target lesion was located in the moderately tortuous and severely calcified superior mesenteric artery (sma).A 6.0x20x75cm express ld balloon expandable stent was selected for use.During the procedure, it was noted that the device did not track through the sma, and the balloon ruptured without being fully inflated.Subsequently, the stent fractured and dislodged from the balloon and got stuck in the sma then migrated down to the popliteal artery.The same issue occurred when another express ld balloon expandable stent was used.The physician attempted to snare the dislodged stents but was unsuccessful.As a result, an emergency cutdown was performed to successfully remove the stents, and the procedure was completed using a non-boston scientific (bsc) stent.The patient was admitted to the hospital beyond the standard of care but is expected to fully recover.It was further reported that the stent was used for mesenteric angiogram.Furthermore, it was noted that the stent was deployed without physician initiating the deployment.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6128757234
• MDR Report Key: 21294720
• Report Number: 2124215-2025-05234
• Device Sequence Number: 9198866
• Product Code: NIO
• UDI-Device Identifier: 08714729579656
• UDI-Public: 08714729579656
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2026
• Device Model Number: H74938046630750
• Device Catalogue Number: H74938046630750
• Device Lot Number: 0031016458
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 02/09/2023
• 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: Required Intervention
• Patient Sex: Unknown