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

Model Number 24657

Device Problems Difficult to Insert (1316); Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

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

Event Date 12/18/2023

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed.This 7x40, 130 cm eluvia drug-eluting vascular stent system was selected for use in a superficial femoral artery angiogram procedure.Difficulty was experienced during insertion of the stent system at the hub of the 6fr sheath.Then it was noticed that the stent had partially deployed, preventing the system from being introduced into the sheath.The device was removed, and a second stent of the same size was successfully deployed.There were no patient complications.

Manufacturer Narrative

Correction to b5: describe event or problem.Correction to h6: device codes.

Event Description

It was reported that the stent inadvertently deployed.This 7x40, 130 cm eluvia drug-eluting vascular stent system was selected for use in a superficial femoral artery angiogram procedure.Difficulty was experienced during insertion of the stent system at the hub of the 6fr sheath.Then it was noticed that the stent had inadvertently deployed, preventing the system from being introduced into the sheath.The device was removed, and a second stent of the same size was successfully deployed.There were no patient complications.

• 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: 18365850
• MDR Text Key: 331008056
• Report Number: 2124215-2023-72544
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876694
• UDI-Public: 08714729876694
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0031905813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1