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

Model Number	H74938046860750
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.Vascular access was obtained via retrograde approach.The 50% stenosed target lesion was located in the mildly tortuous and mild to moderately calcified external iliac artery.A 7f sheath and 0.35 non-boston scientific (bsc) guidewire was advanced, and the diseased lesion was determined using a non-bsc ivus catheter through common and external iliac artery.An 8.0x60x75cm express ld iliac/biliary stent balloon expandable catheter was advanced for treatment.However, resistance was felt when the stent was advanced into common iliac with possible plaque.The stent was removed, and the lesion was dilated with a 6mm balloon catheter.The stent was reinserted again, but still would not advance.The physician placed a 7mmx80 non-bsc stent in the external iliac, and post-dilated with 6mm balloon.The physician reinserted this stent again, but still would not advance.This stent was removed and suspected that the proximal end was damage but could not confirm.A new 7x45 sheath was placed in the common iliac and tried again to reinsert this express ld stent into the sheath, but it was difficult to advance through the hub.The physician inspected again the stent and the damage at the proximal end was confirmed.The procedure was completed using an alternative device.No complications were reported, and the patient was doing well after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination of the returned device confirmed that the balloon was tightly wrapped and had not been subjected to positive pressure.No issues were noted with the balloon material.A visual examination found the stent positioned in the correct location on the balloon.The stent was noted to be damaged.No issues were noted with the tip of the device.A visual and tactile examination identified no issues along the length of the device.The reported allegation of damage stent was confirmed.
Event or Problem Description
It was reported that stent damage occurred.Vascular access was obtained via retrograde approach.The 50% stenosed target lesion was located in the mildly tortuous and mild to moderately calcified external iliac artery.A 7f sheath and 0.35 non-boston scientific (bsc) guidewire was advanced, and the diseased lesion was determined using a non-bsc ivus catheter through common and external iliac artery.An 8.0x60x75cm express ld iliac/biliary stent balloon expandable catheter was advanced for treatment.However, resistance was felt when the stent was advanced into common iliac with possible plaque.The stent was removed, and the lesion was dilated with a 6mm balloon catheter.The stent was reinserted again, but still would not advance.The physician placed a 7mmx80 non-bsc stent in the external iliac, and post-dilated with 6mm balloon.The physician reinserted this stent again, but still would not advance.This stent was removed and suspected that the proximal end was damage but could not confirm.A new 7x45 sheath was placed in the common iliac and tried again to reinsert this express ld stent into the sheath, but it was difficult to advance through the hub.The physician inspected again the stent and the damage at the proximal end was confirmed.The procedure was completed using an alternative device.No complications were reported, and the patient was doing well after the procedure.

• 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: 20675098
• Report Number: 2124215-2024-70891
• Device Sequence Number: 8370684
• Product Code: NIO
• UDI-Device Identifier: 08714729392293
• UDI-Public: 08714729392293
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/03/2024

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 Model Number: H74938046860750
• Device Catalogue Number: H74938046860750
• Device Lot Number: 0033094408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 0.35 GLIDE ADVANTAGE.; GUIDEWIRE: 0.35 GLIDE ADVANTAGE.
• Patient Sex: Unknown