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	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - mid 60's.Date of event estimated using the first day of aware month.Implant date estimated using the first day of aware month.
Event or Problem Description
It was reported that the delivery system was difficult to remove.A 6x100, 130 cm eluvia drug-eluting vascular stent system was selected for use in the extremely tortuous, highly calcified superficial femoral artery (sfa).The eluvia stent was deployed in the sfa, but the delivery system was unable to be pulled back through the non-boston scientific 6f sheath.Therefore, both devices were removed together.Both devices had accordioned due to the heavy calcium.A second stent was placed without incident.No patient complications were reported.
Event or Problem Description
It was reported that the delivery system was difficult to remove.A 6x100, 130 cm eluvia drug-eluting vascular stent system was selected for use in the extremely tortuous, highly calcified superficial femoral artery (sfa).The eluvia stent was deployed in the sfa, but the delivery system was unable to be pulled back through the non-boston scientific 6f sheath.Therefore, both devices were removed together.Both devices had accordioned due to the heavy calcium.A second stent was placed without incident.No patient complications were reported.It was further reported that the target lesion was 70% stenosed.After implanting the stent, the delivery system and wire were removed together.The device was removed intact.The second stent was originally planned as part of this procedure.
Additional Manufacturer Narrative
A2: age at time of event - mid 60's.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16900167
• Report Number: 2124215-2023-22224
• Device Sequence Number: 6819005
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0029333328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F ANSEL COOK SHEATH.; 6F ANSEL COOK SHEATH.
• Patient Sex: Unknown