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 Patient Involvement (2645)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: populated as (b)(6) 2010 as there is no known event date.Populated as the first day of the month of the bsc aware date.
Event or Problem Description
It was reported that stent dislodgement occurred.A 7.0x40x75cm express ld stent was selected for use.However, during preparation it was found out that stent was at the proximal part of the balloon.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A 7.0x40x75cm express ld stent was selected for use.However, during preparation it was found out that stent was at the proximal part of the balloon.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event-: populated as (b)(6) 2010 as there is no known event date.Populated as the first day of the month of the bsc aware date.Device evaluated b mfr: a visual and microscopic examination identified that the stent had been moved to position that was approximately 3mm proximal of the proximal markerband on the device.A microscopic examination found the moved stent to be undamaged.No other issues were identified with the stent that could potentially have contributed to the complaint incident.The balloon was noted to be tightly folded and had not been subjected to positive pressure.A visual and microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.The crimp marks were clearly visible on the balloon material where the stent had been positioned.A visual and microscopic examination identified no issues with the tip of the device during analysis that could have contributed to the complaint incident.A visual and tactile examination identified no damage or any issues along the length of the device.No other issues were identified during the product analysis.

• 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: 9734626
• Report Number: 2134265-2020-01747
• Device Sequence Number: 14053663
• Product Code: NIO
• UDI-Device Identifier: 08714729392217
• UDI-Public: 08714729392217
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 07/01/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024047160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1