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

Model Number 20300

Device Problems Positioning Failure (1158); Defective Device (2588); Material Deformation (2976); Activation Failure (3270); Poor Visibility (4072)

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

Event Date 05/18/2023

Event Type  Injury  

Event Description

It was reported that stent was difficult to view under fluoroscopy, stent expansion failure and stent damage occurred requiring additional intervention.The target lesion was located in the iliac artery.It was severely calcified and tortuous.A 14x60x75 epic stent was advanced for treatment.However, the physician noticed that the stent was not able to deploy well.The stent strut was hard to view under fluoroscopy and it looked like shorter than before.The procedure was completed with a different device.There were no patient complications reported.

Event Description

It was reported that stent was difficult to view under fluoroscopy, stent expansion failure and stent damage occurred requiring additional intervention.The target lesion was located in the iliac artery.It was severely calcified and tortuous.A 14x60x75 epic stent was advanced for treatment.However, the stent was difficult to view under fluoroscopy and was not able to deploy well.The stent was observed to look like shorter than before.The procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: epic ous vas 14x60x75, was received for analysis.The device was received with the stent fully constrained in the correct position on the delivery system.The investigator successfully deployed the stent without issue.No damage was noted to the deployed stent.The stent was measured using calibrated ruler and the stent was found to measure 60mm which is the indicated size of the stent.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no kinks or damage to the sheath of the device.No damage or issues were noted with the handle of the device.

• Brand Name: EPIC
• 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: 17107802
• MDR Text Key: 316979923
• Report Number: 2124215-2023-29340
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2024
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0027355613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male