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

Model Number 24657

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 07/31/2023

Event Type  Injury  

Event Description

Elegance clinical study it was reported that in-stent restenosis occurred, requiring revascularization.On (b)(6) 2021, the subject underwent treatment with this 6x120, 130 cm eluvia drug-eluting vascular stent system as a part of the elegance clinical trial.The 100% stenosed target lesion was located in the right proximal popliteal artery extending up to the right mid-popliteal artery.It had 6mm proximal reference vessel diameter, and 5.5mm distal reference vessel diameter, with lesion length of 150mm.It was classified as transatlantic intersociety consensus (tasc) ii b lesion.Prior to target lesion treatment with the study device, lithotripsy was performed.Treatment of the target lesion was then performed by placement of this study eluvia stent, followed by dilation using study device 6 mm x 150 mm ranger drug-coated balloon.Post-dilation was performed using a non-boston scientific percutaneous transluminal angioplasty balloon and, the final residual stenosis was noted to be 10%.On (b)(6) 2021, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2023, the subject visited the hospital with symptoms related to claudication and was admitted for further medical evaluation and treatment.On the same day, a lower extremity angiogram revealed 60% calcified in-stent restenosis of a non-boston scientific stent and this eluvia stent, which was noted in the right proximal popliteal artery extending up to right mid popliteal artery.On the same day, this was treated by lithotripsy, followed by drug coated balloon angioplasty.Post procedure, the final residual stenosis was noted to be 20%.Post procedure, the subject developed a hematoma at the access site; therefore, femostop was placed which was gradually weaned and removed.On (b)(6) 2023, the event was considered to be resolved.On (b)(6) 2023, the subject was discharged from the hospital on aspirin and plavix.

Manufacturer Narrative

A1: patient id: (b)(6) a2: patient age: 68 years old at time of enrollment.

Event Description

Elegance clinical study it was reported that in-stent restenosis occurred, requiring revascularization.On (b)(6) 2021, the subject underwent treatment with this 6x120, 130 cm eluvia drug-eluting vascular stent system as a part of the elegance clinical trial.The 100% stenosed target lesion was located in the right proximal popliteal artery extending up to the right mid-popliteal artery.It had 6mm proximal reference vessel diameter, and 5.5mm distal reference vessel diameter, with lesion length of 150mm.It was classified as transatlantic intersociety consensus (tasc) ii b lesion.Prior to target lesion treatment with the study device, lithotripsy was performed.Treatment of the target lesion was then performed by placement of this study eluvia stent, followed by dilation using study device 6 mm x 150 mm ranger drug-coated balloon.Post-dilation was performed using a non-boston scientific percutaneous transluminal angioplasty balloon and, the final residual stenosis was noted to be 10%.On (b)(6) 2021, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2023, the subject visited the hospital with symptoms related to claudication and was admitted for further medical evaluation and treatment.On the same day, a lower extremity angiogram revealed 60% calcified in-stent restenosis of a non-boston scientific stent and this eluvia stent, which was noted in the right proximal popliteal artery extending up to right mid popliteal artery.On the same day, this was treated by lithotripsy, followed by drug coated balloon angioplasty.Post procedure, the final residual stenosis was noted to be 20%.Post procedure, the subject developed a hematoma at the access site; therefore, femostop was placed which was gradually weaned and removed.On (b)(6) 2023, the event was considered to be resolved.On (b)(6) 2023, the subject was discharged from the hospital on aspirin and plavix.On (b)(6) 2024, the subject visited the hospital with complaints of right calf cramping on walking for short distances which was relieved with rest.The subject was recommended for peripheral angiography with possible left extremity revascularization on a later date.On (b)(6) 2024, the subject had complaints of progressed claudication symptoms and was scheduled for angiography on (b)(6) 2024.On (b)(6) 2024, the subject visited the hospital for scheduled angiography and was hospitalized for further treatment.On the same day, right lower extremity angiogram was performed which revealed patent right common iliac artery with 30% stenosis, patent external iliac artery, common femoral artery and profunda femoral artery, patent right proximal to mid sfa stents with moderate 50-60% in-stent restenosis, occlusion of the distal sfa and popliteal artery stents with reconstitution distal to the popliteal stent edge with severe calcific disease of the p3 segment and tibio-peroneal trunk, occluded anterior tibial artery and posterior tibial artery with diffuse mid and distal peroneal artery disease with single-vessel peroneal artery runoff to the right foot.On the same day, the subject was treated by laser atherectomy followed by lithotripsy of the popliteal artery and tibio peroneal trunk using 4mm x 40mm and 5 mm x 60 mm balloons and drug coated balloon angioplasty.Residual stenosis in the right distal sfa and above knee popliteal artery stents were treated using 6mm x 120 mm drug coated balloon.There was still an area of resistance at the stent overlap in the distal sfa and popliteal artery which was treated using 5mm x 40mm balloon.Post procedure, the final residual stenosis was noted to be 20%.In addition, severe calcific disease was noted in the p1 and p3 segment of popliteal artery and was treated using 6mm x 60mm balloon.Repeat angiography revealed diminished flow secondary to peroneal artery stenosis which was treated using 2.5mm x 150mm drug coated balloon followed by 3mm x 120 mm balloon.Subsequently, 60% in-stent restenosis was noted in the right mid sfa and was treated using 5mm x 40mm balloon followed by 6mm x 150 mm drug coated balloon.Following treatment, the final residual stenosis was noted to be less than 30%.On (b)(6) 2024, the event was considered to be resolved.On (b)(6) 2024, the subject was discharged from hospital on antiplatelet therapy.

Manufacturer Narrative

A1: patient id: (b)(6).A2: patient age: 68 years old at time of enrollment.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: 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: 18094865
• MDR Text Key: 327663703
• Report Number: 2124215-2023-58272
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028069622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RANGER DCB; RANGER DCB
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White