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

Model Number 39200

Device Problem Difficult to Advance (2920)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).E1 - initial reporter phone: (b)(6).Device evaluated by mfr.: epic vascular 8x80x120, was received for analysis.This epic device is recommended for use with a 0.035-inch guidewire as per epic instructions for use.During the product analysis a boston scientific 0.035-inch guidewire could not be inserted through the device due to damage to the inner sheath.The guidewire used by the customer was not returned for analysis.The device was returned with the stent partially deployed on the delivery system.To facilitate an examination of the inner sheath the investigator fully deployed the stent from the device.No issues or damage was noted with the stent.A visual and tactile examination identified twisting damage to the inner sheath of the device at approximately 75mm proximal of the tip.This type of damage is consistent with the tip of the device being twisted when handling the device, potentially when loading it on to the guidewire.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that tracking difficulties were encountered.Vascular access was obtained via the right femoral artery.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified left femoral artery.After a 6f non-boston scientific (bsc) guide catheter was placed and a 0.035 amplatz guidewire was crossed the lesion, an 8x80x120 epic vascular stent was advanced for treatment.However, the tip of the stent could not cross about 9cm into the end of the guidewire.The problem still occurred even after the physician replaced the guidewire.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable.However, returned device analysis revealed a stent partial deployment.

• Brand Name: EPIC VASCULAR
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17039101
• MDR Text Key: 316338463
• Report Number: 2124215-2023-24942
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805724
• UDI-Public: 08714729805724
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110035
• 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
• Report Date: 06/01/2023

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: 0029251729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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
• Treatment: GUIDEWIRE: 0.035AMPLATZ.; INTRODUCER SHEATH: COOK 6F SHEATH.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 68 KG