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

Model Number	20226
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date.Event date not provided.
Event or Problem Description
It was reported that stent dislodgement occurred.The 65-75% stenosed target lesion was located in the non-tortuous and moderately calcified left iliac artery.A 7.0x40x135 cm express ld stent was advanced for treatment.However, when advancing system out of the sheath, it was noticed that the stent was migrated off from the balloon.The device was removed by pulling back the entire system with the sheath.The procedure was completed with a 7x37 non-bsc stent.There were no patient complications nor injuries 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
• MDR Report Key: 10508205
• Report Number: 2134265-2020-12450
• Device Sequence Number: 3507576
• Product Code: NIO
• UDI-Device Identifier: 08714729392446
• UDI-Public: 08714729392446
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 06/09/2023
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0025576790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR