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

Model Number 20300

Device Problem Positioning Problem (3009)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that positioning difficulty occurred.The target lesion was located in the iliac artery, a 10x60x75 epic stent was advanced for treatment in a percutaneous transluminal angioplasty.However, during deployment, stent jumping was noted.The procedure was completed with another of same device.There were no complications reported and the patient condition was stable.

Event Description

It was reported that positioning difficulty occurred.The target lesion was located in the iliac artery, a 10x60x75 epic stent was advanced for treatment in a percutaneous transluminal angioplasty.However, during deployment, stent jumping was noted.The procedure was completed with another of same device.There were no complications reported and the patient condition was stable.

Manufacturer Narrative

The device was received with the stent fully deployed from the delivery system as it was implanted inside the patient.A visual examination identified no issues with the tip of the device.A visual and tactile examination found no damage or kinks to the sheath of the device.A visual examination identified no issues or damage to the handle of the device.No other issues were identified during the product analysis.

• 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: 18829781
• MDR Text Key: 336812967
• Report Number: 2124215-2024-09531
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0031326598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• 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 Age: 66 YR
• Patient Sex: Male