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

Model Number 24653

Device Problems Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/29/2023

Event Type  malfunction  

Event Description

It was reported that the stent prematurely deployed.This 7x40, 130 cm eluvia drug-eluting vascular stent was selected for use in an endovascular therapy procedure.The 100% stenosed lesion was located in the mildly tortuous and severely calcified superficial femoral artery.During delivery, the tip of the stent protruded slightly from the shaft due to calcification on the lesion.Use of the device was discontinued, and it was removed from the sheath.It was noted the safety lock had been on.Another pre-dilation was performed, and the procedure was completed with a different sized eluvia stent.There was no patient injury.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 7x40, 130 cm eluvia drug-eluting vascular stent system was inspected for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent was partially deployed 8mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The yellow thumbwheel lock and rack were still in the manufactured position.There was blood inside the middle sheath.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis confirmed the stent was partially deployed.

Event Description

It was reported that the stent prematurely deployed.This 7x40, 130 cm eluvia drug-eluting vascular stent was selected for use in an endovascular therapy procedure.The 100% stenosed lesion was located in the mildly tortuous and severely calcified superficial femoral artery.During delivery, the tip of the stent protruded slightly from the shaft due to calcification on the lesion.Use of the device was discontinued, and it was removed from the sheath.It was noted the safety lock had been on.Another pre-dilation was performed, and the procedure was completed with a different sized eluvia stent.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: 17060305
• MDR Text Key: 316898724
• Report Number: 2124215-2023-27500
• 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,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0028764443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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