MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC PERIPHERAL (FORMERLY COVIDIEN VASCULAR / EV3); STENT, ILIAC

Model Number PXB35-06-17-080

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

During the course of a renal stenting in interventional radiography, the stent became dislodged from the device used to place it and was left inside the patient's aorta instead of the renal artery it was intended to be in.Multiple techniques and attempts were made to retrieve the device that ultimately were unsuccessful.The vascular surgeon was able to move the loose stent from the aorta and ultimately left it in the left hypogastric artery but was unable to remove it from the patient.

• Brand Name: MEDTRONIC PERIPHERAL (FORMERLY COVIDIEN VASCULAR / EV3)
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 15410369
• MDR Text Key: 299780052
• Report Number: 15410369
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/01/2022,08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PXB35-06-17-080
• Device Catalogue Number: PXB35-06-17-080
• Device Lot Number: B372128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2022
• Date Report to Manufacturer: 09/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male