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

Model Number	20226
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Used the first day of the month of the bsc aware date since event date was not provided.
Event or Problem Description
It was reported that stent damage occurred.Upon unpacking of an 8.0x30x135cm express ld iliac stent, the proximal stent struts were found to be damaged.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.Upon unpacking of an 8.0x30x135cm express ld iliac stent, the proximal stent struts were found to be damaged.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
(b3) date of event: used the first day of the month of the bsc aware date since event date was not provided.Device evaluated by mfr: a express ld was returned for analysis.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.No issues were noted which may have potentially contributed to the complaint incident.An examination of the crimped stent identified that the proximal end of the stent was damaged where the stent struts had been pushed distally.A visual examination found the stent had moved in a distal direction.A visual and tactile examination identified no issues with the shaft of the device.A visual and tactile examination identified no issues with the tip of this device.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14139895
• Report Number: 2134265-2022-04536
• Device Sequence Number: 4142453
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 08/23/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027897844
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• 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