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

Model Number	20226
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon leak occurred.The patient presented with severe left external iliac artery (eia) stenosis.The 92% stenosed target lesion was located in the moderately tortuous and severely calcified left eia.There was quite a large calcium shelf in the vessel.A 8.0x40x135 cm express ld iliac / biliary stent was advanced; however, during inflation, a contrast was noticed coming from the bottom of the balloon and the balloon would not inflate.The physician thought that it may be the large calcium shelf that caused a pinpoint hole in the bottom of the balloon.The device was removed in whole, and the procedure was completed with a new express ld stent.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
(e1) (b)(6).
Event or Problem Description
It was reported that balloon leak occurred.The patient presented with severe left external iliac artery (eia) stenosis.The 92% stenosed target lesion was located in the moderately tortuous and severely calcified left eia.There was quite a large calcium shelf in the vessel.A 8.0x40x135 cm express ld iliac / biliary stent was advanced; however, during inflation, a contrast was noticed coming from the bottom of the balloon and the balloon would not inflate.The physician thought that it may be the large calcium shelf that caused a pinpoint hole in the bottom of the balloon.The device was removed in whole, and the procedure was completed with a new express ld stent.No patient complications nor injuries were reported.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15865230
• Report Number: 2124215-2022-48997
• Device Sequence Number: 20582029
• Product Code: NIO
• UDI-Device Identifier: 08714729392477
• UDI-Public: 08714729392477
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/05/2022

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: 03/20/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0029080439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/25/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown