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); Thrombosis/Thrombus (4440); Restenosis (4576)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Restenosis guarantee program it was reported that in-stent restenosis occurred, requiring intervention.On (b)(6) 2023, the patient presented for selective left lower extremity arteriogram, atherectomy, balloon angioplasty and stenting of an occluded left superficial femoral artery (sfa).Atherectomy of the sfa was first performed.Then balloon angioplasty was performed to the sfa with a 6 x 200 mm balloon utilizing two overlapping inflations, each held for three minutes.Subsequent imaging showed several areas of significant dissection in the sfa; therefore, a repeat five-minute balloon inflation with the 8 mm balloon was performed.Repeat imaging showed resolution of the most distal dissection, but significant residual dissection in mid-sfa.This 7 x 120 mm eluvia drug-eluting vascular stent system was therefore deployed on the dissection and was post-dilated with a 6 mm balloon.Final imaging showed an excellent result with no significant residual stenosis and no significant dissections.A 6 french percutaneous closure device was deployed in the right common femoral artery which resulted in excellent hemostasis.The patient tolerated the procedure well and was taken to the recovery area in good condition.On (b)(6) 2024, the patient presented with claudication.Selective left lower extremity arteriogram, mechanical thrombectomy, balloon angioplasty and stenting of left superficial femoral artery, atherectomy and balloon angioplasty of left popliteal artery, and intravascular ultrasound were performed.The sfa showed diffuse moderate stenosis proximally and was occluded in the proximal thigh just above the indwelling stent.The stent was occluded and the sfa reconstituted just below the end of the stent in the distal thigh.Mechanical thrombectomy and atherectomy were performed.Atherectomy was deemed necessary to debulk the lesions and reduce the incidence of post-angioplasty dissection.Mechanical thrombectomy of the thrombotic occlusion of the sfa stent was then performed.Repeat imaging showed a patent lumen, but with significant residual stenosis above and below the stent.Balloon angioplasty was performed to the popliteal and sfa with a drug coated balloon, utilizing two overlapping inflations, each for three minutes.Repeat imaging showed possible residual stenosis above and below the stent.Intravascular ultrasound was therefore performed of the left popliteal, sfa, common femoral, external iliac, common iliac and aorta.Findings were a widely patent popliteal artery and significant stenosis of greater than 75% in the proximal sfa.An eluvia 7x120mm drug eluting stent was therefore deployed in the proximal sfa, overlapping the more distal stent by approximately 1 cm.It was post-dilated with a 6 mm balloon.Final imaging showed an excellent result with no significant residual stenosis, brisk flow and preserved run off.A 7 french percutaneous closure device was deployed in the right common femoral artery which resulted in excellent hemostasis.The patient tolerated the procedure well and was taken to the recovery area in good condition.

• 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: 19352759
• Report Number: 2124215-2024-27750
• Device Sequence Number: 7109710
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• 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): 05/20/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030370724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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 Sex: Unknown