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

Model Number 39200

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

It was reported that stent inadvertent deployment occurred.A 10x60x75 epic vascular stent balloon was selected for use in an iliac angioplasty.The device was flushed and loaded onto the wire; however, it was noted that the distal portion of the stent was exposed and partially deployed.The procedure was completed with a new 10x40 epic stent.There were no patient complications reported.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18840299
• MDR Text Key: 336928555
• Report Number: 2124215-2024-12957
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805052
• UDI-Public: 08714729805052
• 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: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0033036460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2023
• 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 Sex: Male
• Patient Race: White