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

Model Number	20188
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Embolism (1829)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: used the first day of the month of aware date since it was not specified.Implant date: 2018.
Event or Problem Description
It was reported that a stent fracture and embolism occurred.A 5.0mmx15mmx90cm express sd stent was deployed on the mesenteric in 2018.This past week of (b)(6) 2020, patient had a mesenteric angiogram and a fracture stent was found along with the vessel being embolized.No further patient complications were reported.
Event or Problem Description
It was reported that a stent fracture and embolism occurred.A 5.0mmx15mmx90cm express sd stent was deployed on the mesenteric in 2018.This past week of (b)(6) 2020, patient had a mesenteric angiogram and a fracture stent was found along with the vessel being embolized.No further patient complications were reported.It was further reported that the distal third of the stent traveled down the superior mesenteric artery and remained in the patient.

• 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: 10726333
• Report Number: 2134265-2020-14654
• Device Sequence Number: 3433157
• Product Code: NIN
• UDI-Device Identifier: 08714729390404
• UDI-Public: 08714729390404
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 08/03/2020
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0020972080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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: Other
• Patient Age: 58 YR