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

Model Number	24657
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a stent fracture occurred requiring additional intervention.The target lesion was severely calcified and mildly tortuous.A 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use.The lesion was predilated with a 6x200 ranger drug coated balloon (dcb).The eluvia device was advanced post dcb; however, resistance was felt and the mid portion of the stent felt tight.The eluvia stent fully expanded and deployed to the expected length.A 6x150 balloon was used for post dilation.A fracture of the eluvia stent was noted post dilation.A covered stent was placed inside the eluvia, long enough to cover the fractured portion of the eluvia stent.There were no patient complications, and the patient is doing fine post procedure.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: 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: 20231354
• Report Number: 2124215-2024-57780
• Device Sequence Number: 15571522
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: 08714729876748
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2026
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0033782490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/16/2024
• Date Device Manufactured: 03/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male