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

Model Number	20188
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date was estimated as it was reported "approximately 2 months prior (end of (b)(6))" to when the issue was noted on imaging.
Event or Problem Description
It was reported that stent fracture and stent migration occurred.In the end of (b)(6) 2019, a 6.0 mm x 18 mm x 90 cm express sd stent was implanted in the left renal artery in an unspecified hospital and by an unspecified physician.On (b)(6) 2019, imaging, at a different hospital than where the stent was implanted, identified that the stent was in a less than ideal spot (mostly hanging into the aorta) and fractured.The physician that found this issue did not perform any interventions when this issue was noted as the patient and their family wished to seek treatment and other medical opinions elsewhere.They did not consent to treat as they were worried about the risk of migration and further complications that could occur with an attempt to remove the stent.No further complications were reported.

• 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: 8920163
• Report Number: 2134265-2019-09695
• Device Sequence Number: 2396909
• Product Code: NIN
• UDI-Device Identifier: 08714729484851
• UDI-Public: 08714729484851
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/22/2019

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: 08/27/2021
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0022574558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/22/2019
• 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