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 Failure (3270)

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

Event Date 01/11/2023

Event Type  malfunction  

Event Description

It was reported that the radial force was insufficient to treat the lesion.An eluvia eu, 6x100, 130 cm was selected for use in the superficial femoral artery (sfa) for the percutaneous angioplasty procedure.The severely tortuous target lesion was reported to be severely calcified.The target lesion was accessed via a contralateral approach using a non-bsc guidewire and non-bsc sheath.When the eluvia was deployed at the target lesion, the physician reported that the stent failed to fully expand, and that the radial force was insufficient to treat the lesion.The lesion was post dilated to ensure the stent was adhered fully to the vessel wall.The procedure was completed and there were no reported adverse consequences to the patient.

Event Description

It was reported that the radial force was insufficient to treat the lesion.An eluvia eu, 6x100, 130 cm was selected for use in the superficial femoral artery (sfa) for the percutaneous angioplasty procedure.The severely tortuous target lesion was reported to be severely calcified.The target lesion was accessed via a contralateral approach using a non-bsc guidewire and non-bsc sheath.When the eluvia was deployed at the target lesion, the physician reported that the stent failed to fully expand, and that the radial force was insufficient to treat the lesion.The lesion was post dilated to ensure the stent was adhered fully to the vessel wall.The procedure was completed and there were no reported adverse consequences to the patient.It was further reported that the reference vessel diameter of the treatment area was 5.5 mm.

Manufacturer Narrative

Updated fields: b5 d3 - manufacturer address 1, manufacturer city, manufacturer state, manufacturer zip/postal code g1 - mfr contact first name, mfr contact last name, mfr contact phone number, mfr contact email h6 - evaluation conclusion codes.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16294415
• MDR Text Key: 308757137
• Report Number: 2124215-2023-04125
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: KS
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0027928216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 94 YR
• Patient Sex: Male