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

Model Number 39200

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 03/05/2021

Event Type  malfunction  

Event Description

It was reported that stent partial deployment occurred.A 12x60x75 epic stent was selected for use.However, the stent was partially deployed when removed from packaging.The procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is partially deployed 1mm from the distal end of the middle sheath.Microscopic examination revealed that the stent is damaged.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the stent partially deployed.

Event Description

It was reported that stent partial deployment occurred.A 12x60x75 epic stent was selected for use.However, the stent was partially deployed when removed from packaging.The procedure was completed with a different device.There were no patient complications reported.

• Brand Name: EPIC VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11569107
• MDR Text Key: 242723315
• Report Number: 2134265-2021-03142
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805199
• UDI-Public: 08714729805199
• Combination Product (y/n): N
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2021
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0020048807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR