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

Model Number 24653

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

Patient Problems Pain (1994); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 10/20/2022

Event Type  Injury  

Event Description

Eminent clinical study: it was reported that in-stent restenosis and thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in right distal superficial femoral artery (sfa) involving proximal popliteal artery with 100% stenosis and was 140 mm long with a proximal reference vessel diameter of 5.5 mm and distal reference vessel diameter of 5 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilatation followed by placement of 6 mm x 120 mm and 6 mm x 60 mm.Following post dilation, residual stenosis was 20%, hence an additional 6 mm x 40 mm study stent was used.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1294 days post index procedure, the subject presented to the hospital with known peripheral arterial occlusive disease (paod) and complained of pain in the right foot which was increasing over the last weeks and symptoms have now also been present at rest for the last two days.Physical examination showed right foot is cool and lividly discolored.On the same day, arterial doppler occlusion pressure at right revealed right brachial artery at rest is 160, dorsalis pedis artery at rest was 0, posterior tibial artery at rest 0.Ankle brachial index (abi) performed revealed at rest (right/left) is -/1.Electronic segment oscillography performed revealed right calf severely pathological, and ankles are severely pathological.On the same day, light reflection plethysmography of the toes both sides revealed severely pathological toe oscillogram.Color coded duplex ultrasound revealed completed repeat occlusion in the right sfa stented from the distal segment and reperfusion in the p3 segment with post-occlusive flow.Based on the symptoms and diagnostic findings the subject was diagnosed with in-stent re-occlusion of distal sfa and apo right leg.Upon consultation, the subject was recommended to undergo interventional procedure for treatment of the event.The subject was hospitalized on the same day for further evaluation and treatment.On (b)(6) 2022, preinterventional angiography on the right side revealed sfa was freely perfused through to the distal segment, then with thrombotic in-stent repeat occlusion with reperfusion in the p2 segment.P3 segment severely stenosed, but freely perfused.Single-vessel lower leg supply, whereby the flow in the anterior tibial artery breaks off in the distal region.On (b)(6) 2022, 1295 days post index procedure, 100% stenosis in right distal sfa involving ppa (target lesion) with lesion length of 210 mm and reference vessel diameter of 6 mm was treated by thrombo-atherectomy using 6f non-boston scientific (bsc) thrombectomy system, followed by cutting balloon angioplasty was performed using 6 mm x 20 mm and later drug coated balloon angioplasty using 4 mm x 80 mm non-bsc balloon.Finally, a drug-coated balloon angioplasty of the tibiofibular [trunk] and the distal p3 segment on the right was performed using 6 mm x 150 mm drug coated non-bsc balloon.Additionally, the intubation of the anterior tibial artery and balloon angioplasty of the proximal outflow segment was performed using 5 mm x 300 mm non-bsc balloon.Later, a recanalization of the distal anterior tibial artery through to the dorsalis pedis artery was performed by balloon angioplasty using 2.0 mm x 20 mm maverick balloon.Post procedure angiography showed good outcome with strong femoropopliteal outflow towards the distal region with no indication of relevant residual stenoses or flow-limiting dissection which resulted in 0% residual stenosis was noted.On (b)(6) 2022, doppler occlusion pressure revealed at right side brachial artery at rest 220, dorsalis pedis artery at rest 120, posterior tibial artery at rest 140.Abi performed on the same day at rest showed at right is 0.6.Electronic segment oscillography right on the same day performed showed normal calf and ankles.Color-coded duplex ultrasound revealed strong biphasic to triphasic perfusion in femoropopliteal artery.Anterior tibial artery with strong biphasic perfusion and strong tibiofibular trunk with biphasic perfused.On (b)(6) 2022, the event was considered to be recovered/resolved and the subject was discharged on the same day in stable condition to home with recommendation of oral anticoagulation medications.

Manufacturer Narrative

Initial reporter facility name: (b)(6).

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15824893
• MDR Text Key: 303905859
• Report Number: 2124215-2022-46822
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022768645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White