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

Model Number	20226
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used (b)(6) 2020 approximating from aware date as the event date was not provided.
Event or Problem Description
It was reported that stent moved on balloon.The target lesion was located in the left profunda vein.A 8.0x30x135cm express ld iliac/biliary stent was selected for use.However, it was noted that the stent was coming off the balloon.The procedure was completed with another express ld stent.No known patient complications were reported.
Event or Problem Description
It was reported that stent moved on balloon.The target lesion was located in the left profunda vein.A 8.0x30x135cm express ld iliac / biliary stent was selected for use.However, it was noted that the stent was coming off the balloon.The procedure was completed with another express ld stent.No known patient complications were reported.It was further reported that during procedure, the balloon came off the shaft of the delivery system with the stent still on the balloon.The device was removed over a wire.
Additional Manufacturer Narrative
Device evaluated by mfr: device was returned for analysis.The balloon was received tightly folded which indicates it had not been subjected to positive pressure.No issues were noted with balloon that could potentially have contributed to the complaint incident.A visual and microscopic examination found that the stent had moved distally by approximately 6mm from its original crimped position.The stent crimping impression was visible on the portion of exposed balloon material.No other issues were identified with the stent.A visual and microscopic examination of the device identified no issues with the markerbands or tip.A visual and tactile examination of the shaft identified no issues.
Event or Problem Description
It was reported that stent moved on balloon.The target lesion was located in the left profunda vein.A 8.0x30x135cm express ld iliac / biliary stent was selected for use.However, it was noted that the stent was coming off the balloon.The procedure was completed with another express ld stent.No known patient complications were reported.It was further reported that during procedure, the balloon came off the shaft of the delivery system with the stent still on the balloon.The device was removed over a wire.

• 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: 10105835
• Report Number: 2134265-2020-07174
• Device Sequence Number: 3016927
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup,Followup
• Report Date (Section B): 07/24/2020

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: 11/11/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024753543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 07/16/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 06/11/2020; 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1