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

Model Number	20226
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the stent moved on balloon.The 80% stenosed target lesion was located in the mildly tortuous superior mesenteric artery.An 8.0x30x135cm express ld iliac / biliary stent was advanced for treatment but the lesion was too tight to cross.The device was removed, and dilatation was performed with a balloon.The stent was being prepared to be loaded onto the 035 non-boston scientific (bsc) guidewire for reintroduction; however, it was noted that the stent had loosened and was not centered on balloon.The device was removed fully intact, and the procedure was completed with a new 75cm-shaft express ld iliac / biliary stent.No patient complications were reported.
Event or Problem Description
It was reported that the stent moved on balloon.The 80% stenosed target lesion was located in the mildly tortuous superior mesenteric artery.An 8.0x30x135cm express ld iliac / biliary stent was advanced for treatment but the lesion was too tight to cross.The device was removed, and dilatation was performed with a balloon.The stent was being prepared to be loaded onto the 035 non-boston scientific (bsc) guidewire for reintroduction; however, it was noted that the stent had loosened and was not centered on balloon.The device was removed fully intact, and the procedure was completed with a new 75cm-shaft express ld iliac / biliary stent.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.A visual examination of the returned device confirmed that the balloon had not been subjected to positive pressure.No issues were noted with the balloon material.The device was received with stent fully mounted on the delivery system.A visual examination identified that the stent had moved distally on the balloon by approximately 8mm.The first and second rows of proximal stent struts were also noted to be damaged.This type of damage is consistent with excessive force being applied to the device, potentially when withdrawing it into the sheath/guide.A visual examination identified no issues with the tip of the device.A visual and tactile examination identified no kinks or damage to the shaft of the device.This concludes the product analysis.

• 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: 19021711
• Report Number: 2124215-2024-15634
• Device Sequence Number: 18137916
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030716778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - .035 ROSEN; GUIDEWIRE - .035 ROSEN
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Race: White