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

Model Number 20188

Device Problems Fracture (1260); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 07/26/2019

Event Type  Injury  

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 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
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8920163
• MDR Text Key: 155174881
• Report Number: 2134265-2019-09695
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729484851
• UDI-Public: 08714729484851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other