MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC

Model Number 39200

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/26/2023

Event Type  Injury  

Event Description

It was reported that tip detachment occurred.The stenosed target lesion was located in the moderately calcified artery.A 9 x 80 x 120 epic stent was advanced for treatment.However, upon remove, it was noted that the tip was missing from the nose cone from the delivery system.Multiple angiograms were done on the vessels.The tip was not radiopaque and there were no embolisms caused from the tip.The detached portion remains inside the patient and they are arranged for a follow up to check the ankle brachial index and an ultrasonogram.

• Brand Name: EPIC VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18208690
• MDR Text Key: 328996189
• Report Number: 2124215-2023-65743
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805861
• UDI-Public: 08714729805861
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female