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

Model Number 24653

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed.An eluvia drug-eluting vascular stent system was selected for use.The target lesion was located in the superficial femoral artery and was reported to be 100% stenosed with moderate tortuosity and severe calcification.The target lesion was predilated prior to advancing the eluvia delivery system.When deployment of the eluvia stent was attempted, the stent partially deployed before failing to deploy fully.The eluvia system was removed and replaced with another eluvia system.The procedure was completed, and there were no reported patient injuries.

Event Description

It was reported that the stent partially deployed.An eluvia drug-eluting vascular stent system was selected for use.The target lesion was located in the superficial femoral artery and was reported to be 100% stenosed with moderate tortuosity and severe calcification.The target lesion was predilated prior to advancing the eluvia delivery system.When deployment of the eluvia stent was attempted, the stent partially deployed before failing to deploy fully.The eluvia system was removed and replaced with another eluvia system.The procedure was completed, and there were no reported patient injuries.It was further reported that the guidewire used in conjunction with the eluvia system was a non-boston scientific 0.035 guidewire.

• 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: 18798593
• MDR Text Key: 337531171
• Report Number: 2124215-2024-11655
• 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: 03/19/2024

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: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0032876866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2023
• 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