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 Hematoma (1884); Ischemia (1942); Pain (1994); Numbness (2415); Paresthesia (4421); Restenosis (4576); Swelling/ Edema (4577)

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

A1: (b)(4).

Event Description

It was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with the eluvia drug-eluting vascular stent system on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right mid superficial femoral artery (sfa) with 5.71 mm proximal reference vessel diameter and 5.56 mm distal reference vessel diameter with lesion length 60 mm.The lesion was 95% stenosis and classified as a tasc ii a lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed using 5.0 mm x 60 mm sterling pta balloon.Treatment of target lesion was performed by placement of a 6 mm x 60 mm eluvia.Post-dilation was performed using 5.0 mm x 100 mm sterling pta balloon and the final residual stenosis was noted to be 0%.On (b)(6) 2023, the subject was discharged from the hospital.On (b)(6) 2023, subject was noted with symptoms related to chronic limb threatening ischemia on the right lower extremity and was admitted to the vascular service.On the same day, lower extremity venous duplex was performed.On (b)(6) 2023, the subject underwent coronary angiogram.On (b)(6) 2023, the subject underwent coronary angiography and subsequent stenting.On (b)(6) 2023, no acute events noted overnight, and the pain in the right foot was unchanged.The subject was scheduled for femoropopliteal bypass with endarterectomy after cardiology clearance with recommendation of holding xarelto for procedure.On (b)(6) 2023, 20 days post-index procedure, right femoral to popliteal bypass graft surgery was performed with reversed great saphenous vein (gsv).Right proximal superficial artery was treated by arteriotomy using size 11 blade followed by endarterectomy.The arteriotomy was closed using vein patch.The harvested gsv was then anastomosed to the proximal sfa in a reversed fashion using 6-0 prolene suture.Arteriotomy was also performed on the popliteal artery using size 11 blade.Gsv was then anastomosed distally to the popliteal artery using 6-0 prolene suture.Following anastomosis, distal pulse and triphasic dp/pt signals were found at the end of the procedure.On (b)(6) 2023, lower extremity arterial exam was performed which revealed right mild flow reduction to the leg and severe flow reduction to the foot at rest was noted.There was improvement in perfusion to the leg.The left leg also revealed mild flow reduction to the leg and foot was noted at rest.

Manufacturer Narrative

A1: (b)(6).

Event Description

It was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with the eluvia drug-eluting vascular stent system on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right mid superficial femoral artery (sfa) with 5.71 mm proximal reference vessel diameter and 5.56 mm distal reference vessel diameter with lesion length 60 mm.The lesion was 95% stenosis and classified as a tasc ii a lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed using 5.0 mm x 60 mm sterling pta balloon.Treatment of target lesion was performed by placement of a 6 mm x 60 mm eluvia.Post-dilation was performed using 5.0 mm x 100 mm sterling pta balloon and the final residual stenosis was noted to be 0%.On (b)(6) 2023, the subject was discharged from the hospital.On (b)(6) 2023, subject was noted with symptoms related to chronic limb threatening ischemia on the right lower extremity and was admitted to the vascular service.On the same day, lower extremity venous duplex was performed.On (b)(6) 2023, the subject underwent coronary angiogram.On (b)(6) 2023, the subject underwent coronary angiography and subsequent stenting.On (b)(6) 2023, no acute events noted overnight, and the pain in the right foot was unchanged.The subject was scheduled for femoropopliteal bypass with endarterectomy after cardiology clearance with recommendation of holding xarelto for procedure.On (b)(6) 2023, 20 days post-index procedure, right femoral to popliteal bypass graft surgery was performed with reversed great saphenous vein (gsv).Right proximal superficial artery was treated by arteriotomy using size 11 blade followed by endarterectomy.The arteriotomy was closed using vein patch.The harvested gsv was then anastomosed to the proximal sfa in a reversed fashion using 6-0 prolene suture.Arteriotomy was also performed on the popliteal artery using size 11 blade.Gsv was then anastomosed distally to the popliteal artery using 6-0 prolene suture.Following anastomosis, distal pulse and triphasic dp/pt signals were found at the end of the procedure.On (b)(6) 2023, lower extremity arterial exam was performed which revealed right mild flow reduction to the leg and severe flow reduction to the foot at rest was noted.There was improvement in perfusion to the leg.The left leg also revealed mild flow reduction to the leg and foot was noted at rest.Additional information was received with details regarding the initial symptoms of ischemia the patient presented with on (b)(6) 2023, including extremity knee pain radiating distally with numbness and tingling.Additionally, subject was also complained of worsening antero-medial wound.Physical examination revealed warm, dry and pink skin with diffuse pigmented discoloration of right calf, ankle and foot.Additional details also indicated an unrelated issue on (b)(6) 2023, where the subject was noted to have gastrointestinal bleeding, egd performed revealed duodenal ulcer.On the same day, subject was transferred to ir and gastroduodenal artery coiling was performed.On (b)(6) 2023, the subject was transferred out of the icu to the floor as the subject was hemodynamically stable.On (b)(6) 2023, subject's hospital course was complicated by swelling of right lower extremity and amputation site of second right toe was noted with bogginess and foul smelling.Right lower extremity doppler performed revealed no bilateral deep vein thrombosis and possible hematoma from thigh to calf.On (b)(6) 2023, stenting of right superficial femoral artery into gsv followed by balloon angioplasty of anterior tibial artery and peroneal artery was performed.On the same day, excisional debridement of necrotic plaque in right leg and right trans-metatarsal amputation was performed.On (b)(6) 2023, wound vac was placed.On (b)(6) 2023, the subject was hemodynamically stable and was discharged from the hospital on aspirin.

• 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: 18268068
• MDR Text Key: 329739809
• Report Number: 2124215-2023-68834
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876588
• UDI-Public: 08714729876588
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030904769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White