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

Model Number 39200

Device Problems Difficult to Insert (1316); Premature Activation (1484)

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

Event Date 09/09/2022

Event Type  malfunction  

Event Description

It was reported that inadvertent deployment occurred.The target lesion was located in a severely tortuous vessel in the left forearm.A 9x40x75 epic vascular stent was selected for use.However, during preparation, the physician attempted to load the stent onto the guidewire but could not advance it into the sheath because the stent started to deploy.They tried to see if the stent would get covered by delivery system but could not.The procedure was completed with an innova self-expanding stent.No patient complications were reported.

• Brand Name: EPIC VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15547050
• MDR Text Key: 302717456
• Report Number: 2124215-2022-36732
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805793
• UDI-Public: 08714729805793
• 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
• Type of Report: Initial
• Report Date: 10/05/2022

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: 0029475219
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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