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

Model Number 39202

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

It was reported that difficulty in removing from guidewire occurred.The 100% stenosed target lesion was located in severely tortuous and severely calcified common iliac artery.After crossing the lesion with a non-bsc guidewire, a 9 x 100 x 75 epic stent was advanced and successfully deployed.An attempt to withdraw the delivery system was made, but it was difficult to remove and was stuck together with the non-bsc guidewire.Both devices were removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.

Manufacturer Narrative

H6 - device codes: corrected to 'entrapment of device' and 'difficult to remove.

Event Description

It was reported that difficulty in removing from guidewire occurred.The 100% stenosed target lesion was located in severely tortuous and severely calcified common iliac artery.After crossing the lesion with a non-bsc guidewire, a 9 x 100 x 75 epic stent was advanced and successfully deployed.An attempt to withdraw the delivery system was made, but it was difficult to remove and was stuck together with the non-bsc guidewire.Both devices were removed and the procedure was completed with another of the same device.There were no patient complications nor injuries 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: 18383876
• MDR Text Key: 331241937
• Report Number: 2124215-2023-72857
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805892
• UDI-Public: 08714729805892
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

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: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0030544669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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