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); Difficult to Advance (2920)

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

Event Date 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent was partially deployed 10mm from the middle sheath.Microscopic and further inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis confirmed the reported event of premature deployment.

Event Description

It was reported that the stent was prematurely deployed when advancing onto the guidewire.An eluvia eu, 7x60, 130 cm was selected for use in the superficial femoral artery (sfa) to treat the patient's stenosis.During device preparation, the eluvia delivery system was attempted to be advanced over the amplatz super stiff guidewire 0.035 in, but resistance was encountered.To facilitate advancement, the physician pushed the catheter from the tip, which resulted in a partial stent deployment outside of the patient.Additionally, a polymer-like material was noted on the table, which was suspected to be from the eluvia.Of note, no foreign matter was noted on the eluvia or in the device packaging.The eluvia and amplatz were both replaced in order to complete the procedure.The procedure was completed and there were no adverse consequences reported for the patient.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16414527
• MDR Text Key: 309972084
• Report Number: 2124215-2023-06711
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0028482136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1