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); Discomfort (2330); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 07/19/2023

Event Type  Injury  

Event Description

Eminent clinical study: it was reported there was in-stent occlusion/thrombosis.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 the left proximal and distal sfa with 100% stenosis and was 130 mm long with a proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.0 mm (classified as a tasc ii c lesion).Target lesion was treated with pre-dilatation, followed by placement of 6 mm x 80 mm and 6 mm x 120 mm eluvia study stents.Since the treatment with outback was done, hence a 6 mm x 40 mm eluvia study stent was necessarily implanted again for treating the target lesion with 20% residual stenosis.Post dilatation was also performed.On (b)(6) 2019 the subject was discharged with antiplatelet therapy.On (b)(6) 2023, 1458 days post index procedure, the subject has presented to the hospital for evaluation due to known peripheral artery disease (pad) and complained of having left leg pain for 2 weeks with spontaneous shooting pain in the left thigh while mowing the lawn (which had spread to the left lower leg).Since then, the subject felt discomfort while walking after approximately 200 meters.The subject also complained of severe back pain in the left paravertebral region for a long time, however subject associates these with increasing pain in the area of the leg.On the same day, the subject was hospitalized for further evaluation and treatment.Upon physical examination, left foot was slight cooler than right, posterior tibial artery was not palpable on the left and popliteal pulses were not palpable on the left.Arterial doppler occlusion pressures performed at rest in the left leg showed brachial artery was 140, dorsalis pedis artery was 50 and posterior tibial artery was 60.Ankle-brachial index (abi) performed on the same day at rest was 0.4 on left and 0.9 on right.Electronic segment oscillography performed showed moderate pathological thigh, severely pathological calf and ankle region was not seen.Also, severely pathological digits from i to v was seen on the left side.The subject was already taking aspirin and clopidogrel.The color duplex ultrasound examination revealed very small stenosed deep femoral artery on the left, pronounced calcified plagues, right femoropopliteal artery diffuse only <50%, but narrow vessels in places only 3 mm and left proximal superficial femoral artery was still patent, followed by occlusion was seen including p1 segment, post-occlusive flow was noted in the p2/p3 segment.Based on the symptoms and diagnostic findings the subject was diagnosed with in-stent re-occlusion of the left superficial femoral artery.Upon consultation, the subject was recommended for the interventional procedure as a treatment for the event.Pre-interventional angiogram performed revealed occlusion was seen in the deep femoral artery.The superficial femoral artery was stented proximally to distally, occlusion was seen proximally with reperfusion in the femoropopliteal junction segment; however, popliteal artery, tibiofibular trunk, posterior tibial artery with plantar artery and fibular artery was noted without any significant narrowing.On (b)(6) 2023, the 100% stenosis in left proximal, mid and distal sfa with 260 mm lesion length and a reference vessel diameter of 5 mm was treated by performing rotational atherectomy and thrombectomy by using 6f non-boston scientific (bsc) atherectomy catheter.After atherectomy, 60% to 70% of residual stenosis was noted, so overlapping of drug-coated balloon angioplasty was performed using two 6 mm x 150 mm non-bsc balloons.Additionally, deep femoral artery was also treated using 6 mm x 40 mm ranger drug-coated balloon.Post procedure, there were no complications and thrombus was noted resulting in 30% residual stenosis.On (b)(6) 2023, arterial doppler occlusion pressures performed at rest in the left leg showed dorsalis pedis artery was 70 and posterior tibial artery was 110 and brachial artery was not detected.Ankle-brachial index (abi) performed on the same day at rest was 0.8 on left and 1 on right.Electronic segment oscillography performed showed mildly pathological thigh, normal calf and mildly pathological ankle.On the same day, follow up duplex ultrasound revealed strong monophasic perfusion of the deep femoral artery without ostial stenosis associated with adequate flow as far as traceable.High plaque load especially at proximal region of the superficial femoral artery and focal moderate stenosis (psv 290 cm/s, proximal pvr 3.1) was also noted.Additionally, strong femoropopliteal monophasic flow was observed.On (b)(6) 2023, the subject was discharged in a stable condition with the advice of three-month intensified antiplatelet therapy with asa 100 mg plus clopidogrel 75 mg.This was to be followed by long-term treatment with asa 100 mg daily and also biannual angiology follow-up was recommended.

• 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: 17503012
• MDR Text Key: 320853993
• Report Number: 2124215-2023-42722
• 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: Other,Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023125662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: White