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

Model Number	20188
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent dislodged.The target lesion was located in a renal artery.A 7.0mmx15mmx150cm express sd stent was advanced for treatment with a 6fr guide catheter.During procedure, the stent was unable to cross the lesion and the stent came off the balloon and landed in external iliac artery.The stent was deployed to 7.5mm so it would be opposed to the vessel wall instead of trying to retrieve it.A 5mm balloon was used to pre-dilate the renal artery and another stent was successfully deployed in the target lesion with the used of a guide.No patient complications were reported and the patient 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: 8636959
• Report Number: 2134265-2019-05729
• Device Sequence Number: 16711257
• Product Code: NIN
• UDI-Device Identifier: 08714729390435
• UDI-Public: 08714729390435
• 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
• Device Implanted Year: 2019
• 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: 12/11/2020
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0021504344
• 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: 82 YR