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

Model Number	20226
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was not returned for analysis.However, an image depicting the express ld device stuck in a 6fr introducer sheath was received.From the image it can be observed that the balloon was not inflated.The stent was also noted to be damaged and had moved proximally on the balloon.The proximal end of the stent was bunched as it entered the light green 6fr introducer sheath.
Event or Problem Description
Reportable based on investigation completed on 19jun2020.It was reported that advancing difficulties were encountered.The target lesion was located in the iliac artery.A 7.0x60x75cm express ld iliac / biliary stent was selected for use.However, the physician could not advance the stent through the sheath due to severe scarring at the entry site.Both the device and the sheath was removed and another 7fr sheath was used.The procedure was completed with a different device.No patient complications reported.However, investigation revealed stent damage and stent moved on balloon.

• 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: 10200079
• Report Number: 2134265-2020-08558
• Device Sequence Number: 14011905
• Product Code: NIO
• UDI-Device Identifier: 08714729392231
• UDI-Public: 08714729392231
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/26/2020

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: 12/11/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024917858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1