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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in-stent restenosis occurred, requiring an additional intervention.On (b)(6) 2023, an aortogram, left lower extremity arteriogram, atherectomy, balloon percutaneous transluminal angioplasty, and stenting procedure was performed.The superficial femoral artery lesion was occluded at its origin.The lesion was unable to be accessed via the right common femoral artery; therefore, the left pedis artery was accessed and the lesion was accessed from below.Atherectomy was performed, followed by balloon angioplasty using two overlapping inflations, each held for three minutes.A significant dissection occurred at the origin of the sfa due to the nature of the disease and patient anatomy, and not due to any device per the physician.An additional five-minute inflation was performed with the balloon, with little improvement.Therefore, this 7x40, 130 cm eluvia drug-eluting vascular stent system was deployed.Repeat imaging showed a good result.Then another balloon was advanced into the dorsalis pedis artery to achieve hemostasis.The micropuncture dilator was removed prior to inflating the balloon across the access site and was held for three minutes.Repeat imaging showed sluggish flow in the anterior tibial artery which was attributed to spasm.Therefore, intra-arterial nitroglycerin was administered and repeat imaging showed improvement.On (b)(6) 2023 selective left lower extremity arteriogram was performed due to peripheral artery disease with claudication.This showed the sfa was occluded at its origin and an occluded stent in the sfa.An attempt was made to advance a non-boston scientific guidewire; however, was unable to advance to the stent.The procedure was terminated, and the patient would return for follow up to discuss possible left femoral-popliteal bypass.

• 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: 17885054
• Report Number: 2124215-2023-50915
• Device Sequence Number: 6797847
• Product Code: NIU
• UDI-Device Identifier: 08714729876694
• UDI-Public: 08714729876694
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 10/06/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0029781631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2022
• 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: 68 YR
• Patient Sex: Male