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

Model Number 20300

Device Problem Difficult to Advance (2920)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that procedure got cancelled/rescheduled.A 8x60x75 epic stent was advanced for use.However, the guidewire failed to advance through the epic stent delivery system.The procedure was then cancelled.No further information was provided.

Manufacturer Narrative

B3 - date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: returned product consisted of an epic stent delivery system.The device was visually and microscopically investigated for damage.The device showed a kink located 69.7cm from the distal end of the marker band.The stent was in the device.It was noticed that the yellow rack lock was not affixed to the device or sent back with the device.A.035 amplatz stiff guidewire was inserted into the devices tip and the wire transcended through the device until it reached the kink.The wire would not cross the kinked area due to the damage noticed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that procedure got cancelled/rescheduled.A 8x60x75 epic stent was advanced for use.However, the guidewire failed to advance through the epic stent delivery system.The procedure was then cancelled.No further information was provided.

• Brand Name: EPIC
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12883947
• MDR Text Key: 281339921
• Report Number: 2134265-2021-14964
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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 Expiration Date: 09/30/2023
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0026106981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• 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