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

Model Number	H74939294701210
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that occlusion occurred, requiring medical intervention and additional device.On (b)(6) 2025, the patient with severe peripheral vascular disease (pvd) and chronic limb-threatening ischemia (clti) presented with ulceration of the left calf.The patient required an intervention due to severe stenosis and occlusions in the left superficial femoral artery (sfa), above-knee popliteal artery, and tibioperoneal trunk.The procedure was performed under monitored conscious sedation (iv versed and fentanyl) with local anesthesia using 1% lidocaine.The right common femoral artery (cfa) was accessed retrogradely under ultrasound guidance, and a 5f sheath was placed.The left lower extremity was selectively catheterized, including the left common femoral, superficial femoral, popliteal, anterior tibial, and peroneal arteries.Angiographic findings revealed total occlusion of the left sfa at the origin, reconstitution distally at hunter's canal, with severe disease in the above-knee popliteal artery and a dominant posterior tibial artery for single-vessel runoff.The left tibioperoneal trunk and posterior tibial artery showed severe stenosis with circumferential calcification, while the anterior tibial and peroneal arteries were totally occluded.Intravascular ultrasound (ivus) showed circumferential calcification in the left sfa, above-knee popliteal, and posterior tibial artery.The procedure involved atherectomy and balloon angioplasty of the left sfa and popliteal artery, restoring wide patency.Atherectomy and balloon angioplasty of the tibioperoneal trunk and posterior tibial artery were also performed.Intravascular ultrasound confirmed the severity of stenosis in the sfa, popliteal artery, and posterior tibial artery, as well as the effectiveness of the interventions.After balloon dilatation, a 7 x 120 mm eluvia drug-coated stent was placed at the origin of the left sfa, followed by post-dilation with a 7 x 120 mm balloon to optimize stent expansion.Repeat angiography showed restored patency of the left sfa, above-knee popliteal artery, and tibioperoneal trunk, with preservation of flow to the foot through the posterior tibial artery.Hemostasis was achieved using a starclose device.The patient tolerated the procedure well and was transferred to the recovery area in stable condition.On (b)(6) 2025, the patient with chronic limb-threatening ischemia (clti) due to atherosclerosis of the native arteries of the left leg presented with ulceration and recurrent occlusion of the left superficial femoral artery (sfa).The patient underwent a repeat intervention due to restenosis of a previously placed sfa stent and total occlusion of the femoropopliteal arteries.The procedure was performed under monitored conscious sedation with iv versed and fentanyl, and local anesthesia with 1% lidocaine.The right common femoral artery (cfa) was accessed retrogradely using ultrasound guidance, and a 5f sheath was placed.A working sheath was advanced, and selective catheterization was performed for the left lower extremity, including the left common femoral, superficial femoral, popliteal, anterior tibial, and peroneal arteries.Angiographic findings revealed a widely patent aortoiliac system and femoropopliteal segment, but with total occlusion of the left sfa and previously placed stent (7 mm x 120 mm).The left popliteal artery was patent above and below the knee, with a single-vessel runoff via the posterior tibial artery.Intravascular ultrasound (ivus) confirmed the patency of the left common femoral artery (8 mm) and revealed total occlusion of the left sfa with a 7 mm x 120 mm stent and stenosis in the popliteal artery (6 mm).The procedure involved atherectomy, angioplasty, and stent placement in the left sfa, restoring wide patency.A 7 x 150 mm eluvia drug-coated stent was deployed, overlapping the previous stent, followed by post-dilation with a 6 x 200 mm balloon.Additional balloon dilation was performed with a 7 x 220 mm balloon to optimize stent expansion.In the distal superficial femoral artery, there was a mild compression of the eluvia stent noticed on repeat intravascular ultrasound so at this point even after ballooning with a 7mm balloon, this persisted; therefore, a final 8 x 39 balloon was placed at the distal sfa which opened the stent.The posterior tibial artery was widely patent with no evidence of distal embolization.The patient was given intravenous heparin (10,000 units total) during the procedure, and repeat angiography demonstrated restored wide patency of the left sfa, popliteal artery, and tibioperoneal trunk.Flow to the foot was preserved through the posterior tibial and peroneal arteries.The vascular sheaths were removed, and hemostasis was achieved using a starclose device.The patient tolerated the procedure well and was transferred to the recovery area in stable condition.
Additional Manufacturer Narrative
E1 - initial reporter email: updated.
Event or Problem Description
It was reported that occlusion occurred, requiring medical intervention and additional device.On (b)(6) 2025, the patient with severe peripheral vascular disease (pvd) and chronic limb-threatening ischemia (clti) presented with ulceration of the left calf.The patient required an intervention due to severe stenosis and occlusions in the left superficial femoral artery (sfa), above-knee popliteal artery, and tibioperoneal trunk.The procedure was performed under monitored conscious sedation (iv versed and fentanyl) with local anesthesia using 1% lidocaine.The right common femoral artery (cfa) was accessed retrogradely under ultrasound guidance, and a 5f sheath was placed.The left lower extremity was selectively catheterized, including the left common femoral, superficial femoral, popliteal, anterior tibial, and peroneal arteries.Angiographic findings revealed total occlusion of the left sfa at the origin, reconstitution distally at hunter's canal, with severe disease in the above-knee popliteal artery and a dominant posterior tibial artery for single-vessel runoff.The left tibioperoneal trunk and posterior tibial artery showed severe stenosis with circumferential calcification, while the anterior tibial and peroneal arteries were totally occluded.Intravascular ultrasound (ivus) showed circumferential calcification in the left sfa, above-knee popliteal, and posterior tibial artery.The procedure involved atherectomy and balloon angioplasty of the left sfa and popliteal artery, restoring wide patency.Atherectomy and balloon angioplasty of the tibioperoneal trunk and posterior tibial artery were also performed.Intravascular ultrasound confirmed the severity of stenosis in the sfa, popliteal artery, and posterior tibial artery, as well as the effectiveness of the interventions.After balloon dilatation, a 7 x 120 mm eluvia drug-coated stent was placed at the origin of the left sfa, followed by post-dilation with a 7 x 120 mm balloon to optimize stent expansion.Repeat angiography showed restored patency of the left sfa, above-knee popliteal artery, and tibioperoneal trunk, with preservation of flow to the foot through the posterior tibial artery.Hemostasis was achieved using a starclose device.The patient tolerated the procedure well and was transferred to the recovery area in stable condition.On (b)(6) 2025, the patient with chronic limb-threatening ischemia (clti) due to atherosclerosis of the native arteries of the left leg presented with ulceration and recurrent occlusion of the left superficial femoral artery (sfa).The patient underwent a repeat intervention due to restenosis of a previously placed sfa stent and total occlusion of the femoropopliteal arteries.The procedure was performed under monitored conscious sedation with iv versed and fentanyl, and local anesthesia with 1% lidocaine.The right common femoral artery (cfa) was accessed retrogradely using ultrasound guidance, and a 5f sheath was placed.A working sheath was advanced, and selective catheterization was performed for the left lower extremity, including the left common femoral, superficial femoral, popliteal, anterior tibial, and peroneal arteries.Angiographic findings revealed a widely patent aortoiliac system and femoropopliteal segment, but with total occlusion of the left sfa and previously placed stent (7 mm x 120 mm).The left popliteal artery was patent above and below the knee, with a single-vessel runoff via the posterior tibial artery.Intravascular ultrasound (ivus) confirmed the patency of the left common femoral artery (8 mm) and revealed total occlusion of the left sfa with a 7 mm x 120 mm stent and stenosis in the popliteal artery (6 mm).The procedure involved atherectomy, angioplasty, and stent placement in the left sfa, restoring wide patency.A 7 x 150 mm eluvia drug-coated stent was deployed, overlapping the previous stent, followed by post-dilation with a 6 x 200 mm balloon.Additional balloon dilation was performed with a 7 x 220 mm balloon to optimize stent expansion.In the distal superficial femoral artery, there was a mild compression of the eluvia stent noticed on repeat intravascular ultrasound so at this point even after ballooning with a 7mm balloon, this persisted; therefore, a final 8 x 39 balloon was placed at the distal sfa which opened the stent.The posterior tibial artery was widely patent with no evidence of distal embolization.The patient was given intravenous heparin (10,000 units total) during the procedure, and repeat angiography demonstrated restored wide patency of the left sfa, popliteal artery, and tibioperoneal trunk.Flow to the foot was preserved through the posterior tibial and peroneal arteries.The vascular sheaths were removed, and hemostasis was achieved using a starclose device.The patient tolerated the procedure well and was transferred to the recovery area in stable condition.

• Brand Name: ELUVIA?
• 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: 23656740
• Report Number: 2124215-2025-85780
• Device Sequence Number: 11987763
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: (01)08714729876731(17)260816(10)34929607
• 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: 2025
• 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): 12/22/2025

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: 08/16/2026
• Device Model Number: H74939294701210
• Device Catalogue Number: H74939294701210
• Device Lot Number: 0034929607
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/22/2025
• Date Device Manufactured: 08/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER - 035 RUBICON.; CATHETER - 035 RUBICON.; CATHETER - 035 RUBICON.; CATHETER - 035 RUBICON.; CATHETER - BERENSTEIN.; CATHETER - BERENSTEIN.; CATHETER - OMNIFLUSH.; CATHETER - OMNIFLUSH.; CATHETER - OMNIFLUSH.; CATHETER - OMNIFLUSH.; GUIDEWIRE - 009 ROTA WIRE.; GUIDEWIRE - 009 ROTA WIRE.; GUIDEWIRE - 035 ZIPWIRE.; GUIDEWIRE - 035 ZIPWIRE.; GUIDEWIRE - 035 ZIPWIRE.; GUIDEWIRE - 035 ZIPWIRE.; GUIDEWIRE - ROSEN.; GUIDEWIRE - ROSEN.; GUIDEWIRE - ROSEN.; GUIDEWIRE - ROSEN.; GUIDEWIRE - V18.; GUIDEWIRE - V18.; GUIDEWIRE - V18.; GUIDEWIRE - V18.; IVUS CATHETER - PHILIPS 018.; IVUS CATHETER - PHILIPS 018.; IVUS CATHETER - PHILIPS 018.; IVUS CATHETER - PHILIPS 018.; WORKING SHEATH - 6F 45CM.; WORKING SHEATH - 6F 45CM.; WORKING SHEATH - 8F 45CM.; WORKING SHEATH - 8F 45CM.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: Black Or African American