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

Model Number	20226
Medical Device Problem Codes	Fracture (1260); Defective Device (2588); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event: date of event was not provided.
Event or Problem Description
It was reported that the device broke, and a piece remained inside the patient.This 8.0x40x135 cm express ld iliac / biliary was reported to have broken and a piece remained inside the patient.Additional details have been requested but are unavailable at this time.
Additional Manufacturer Narrative
B3: date of event: date of event was not provided.
Event or Problem Description
It was reported that the device broke, and a piece remained inside the patient.This 8.0x40x135 cm express ld iliac / biliary was reported to have broken and a piece remained inside the patient.Additional details have been requested but are unavailable at this time.It was further reported that during a procedure for an acute type b aortic dissection and occluded celiac artery with malperfusion of the superior mesenteric artery (sma), a non-boston scientific dissection stent was placed extending distally.The sma was still stenosed; therefore, this 8.0x40x135 cm express ld iliac / biliary stent was placed to open the sma origin.Subsequent routine imaging was performed which demonstrated that the stent fractured with one part remaining in the sma origin and the other dislodged distally in the sma trunk.This fractured sma stent was then opposed to the sma wall with balloon angioplasty, and then it was attempted to try to reline the sma stent to trap the piece that migrated distally.The patient did not have any symptoms from this and the sma remained open.

• 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: 19615128
• Report Number: 2124215-2024-38938
• Device Sequence Number: 6112396
• Product Code: NIO
• UDI-Device Identifier: 08714729392477
• UDI-Public: 08714729392477
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 09/12/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030135344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/11/2024
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown