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	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 10-may 2022.It was reported that shaft kink occurred.The stenosed target lesion was located in the left subclavian artery.A 7.0x30x135cm express ld iliac / biliary stent was advanced to treat the lesion.However, during introduction, it was found that the 7fr introducer sheath was folded and the shaft was kinked after passing through the knob.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed stent damage.
Additional Manufacturer Narrative
Age at time of event: (b)(6) or older.Device evaluated by mfr.: a express ld device 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 4th and 5th row of stent struts on the distal region were lifted and bunched.A visual and tactile examination identified no issues with the shaft of the device.A visual and tactile examination identified no issues with 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: 14568472
• Report Number: 2134265-2022-05504
• Device Sequence Number: 12032669
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: 08714729579694
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 04/09/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0023622397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2019
• 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