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

Model Number	20226
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the superficial femoral artery.A 7.0x30x135cm express ld stent was advanced for treatment.However, the device was caught on the sheath and the stent was defective.Subsequently, another 7.0x30x135cm express ld stent was advanced but the device was also caught on the sheath and was also defective.Both devices were retrieved, and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for analysis.The balloon was received tightly folded which indicates it had not been subjected to positive pressure.The stent was pushed in a distal direction over the distal markerband.No damage or issues were noted with balloon material or stent that could potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination of the device identified no issues with the tip that could have contributed to the complaint incident.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the superficial femoral artery.A 7.0x30x135cm express ld stent was advanced for treatment.However, the device was caught on the sheath and the stent was defective.Subsequently, another 7.0x30x135cm express ld stent was advanced but the device was also caught on the sheath and was also defective.Both devices were retrieved, and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

• 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: 16109340
• Report Number: 2124215-2022-54550
• Device Sequence Number: 7654274
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: 08714729579694
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/01/2023

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: 10/23/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030311484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Patient Sex: Unknown