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 Code Available (3191)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The more than 90% stenosed target lesion was located in the severly tortuous left common and external iliac arteries.A 9.0x40x75cm express ld iliac / biliary stent was advanced for treatment.However, it was noted that the stent came off its balloon when removing the stent to exchange guidewires.The balloon was removed and the undeployed stent was seen in the sheath inside the body.The physician used a small balloon and inserted it through the undeployed stent which was then subsequently advanced and deployed safely into the external iliac artery (eia).After stent implantation in the eia, another 9.0x40x75cm express ld stent was handed off to treat the left common iliac artery.However, it was noticed that the balloon in which the stent is mounted was winged out at the distal portion.The physician decided not to used the stent and finished the procedure with another of the same device.No harm was caused to the patient.

• 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: 10345150
• Report Number: 2134265-2020-10188
• Device Sequence Number: 2309998
• Product Code: NIO
• UDI-Device Identifier: 08714729392330
• UDI-Public: 08714729392330
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0021615968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention