MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

It was reported that the stent was difficult to deploy and was damaged.This 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in an endovascular therapy procedure.The 100% stenosed, severely calcified, and severely tortuous lesion was located in the right superficial femoral artery.A contralateral approach was performed.After the non-boston scientific introducer sheath was placed, an attempt was made with the guidewire to cross the chronic total occlusion (cto) lesion, but it was unable to cross.The true lumen was captured with a cto wire, and it was able to cross.Pre-inflation was performed with a small-diameter long balloon and inflation was performed again with another balloon, but the calcification was severe.The patient was noted to have chronic limb threatening ischemia, and revascularization was required to be performed; therefore, it was decided to place this eluvia stent.During deployment, resistance was felt, and the stent seemed to be caught in the calcification.It was thought that there was a possibility of a kink because of the resistance felt.However, when the stent was placed and while checking its position, it was slightly difficult to open midway of the deployment.Deployment was continued while pulling the thumbwheel and the pull grip.The stent was implanted, and because the lesion was long, an additional stent was deployed and placed, and the procedure was completed with a post-inflation.There was no patient injury.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• 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: 18322937
• MDR Text Key: 330467871
• Report Number: 2124215-2023-70920
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0030943620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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