MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	20188
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The 99% stenosed target lesion was located in the superior mesenteric artery.A 6.0mmx18mmx150cm express sd stent was advanced for treatment, however, the device failed to cross the lesion several times and the stent came off the balloon.The physician tried to snare it but was unsuccessful and it went into the aorta.The dislodged stent landed in the right internal iliac artery where the physician left it.The procedure was completed with a non-bsc stent.No patient complications were reported and the patient's status was fine.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8636935
• Report Number: 2134265-2019-05695
• Device Sequence Number: 1876213
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• 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): 05/23/2019

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: 09/25/2021
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0022707692
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/23/2019
• 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: Other
• Patient Age: 68 YR