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

Model Number	20226
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement and removal difficulties occurred.The target lesion was located in the right lower extremity.After a 6f introducer sheath was introduced in the lesion, an 8.0x40x75cm express ld stent was advanced into the sheath; however, when the physician pushed the stent, it slipped off the balloon.When the physician tried to remove the device out of the sheath, the stent became stuck in the sheath.An alligator forceps was used to completely remove the stent out of the patient's body and the procedure was ended.No patient complications were reported and the patient's status is fine, just a sore groin.

• 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: 7881390
• Report Number: 2134265-2018-61033
• Device Sequence Number: 13935066
• Product Code: NIO
• UDI-Device Identifier: 08714729392279
• UDI-Public: 08714729392279
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/17/2018

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: 01/04/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0021573440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/17/2018
• 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