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); Numbness (2415); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 05/24/2023

Event Type  Injury  

Manufacturer Narrative

A2: age at time of event - 70 years old at the time of study enrollment.

Event Description

Eminent clinical study: it was reported that stent thrombosis and in-stent re-occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2019, and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) involving proximal popliteal artery (ppa) with 100% stenosis.It was 140 mm long with a proximal reference vessel diameter of 5.5 mm and a distal reference vessel diameter of 5.0 mm.It was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation, followed by placement of 6 mm x 120 mm and 6 mm x 60 mm study stents.Since residual stenosis was noted post procedure, a 6 mm x 40 mm study stent was implanted.Post dilatation was performed, and the final residual stenosis was 20%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2023, 1510 days post index procedure, the subject presented to the hospital with sudden onset of pain in the right leg since yesterday, currently with nocturnal pain at rest and hypoesthesia on the right with no wounds.Physical examination revealed no edema, and both feet were cool.On the same day the subject was admitted for further evaluation and treatment.Subject was classified as rutherford category 5, fontaine stage iii on the right leg with a small heel ulcer on the right.At the time of event reporting, the subject was on regular use of xarelto and discontinued clopidogrel four weeks ago.Duplex ultrasound examination performed on the same day for the right leg revealed no stenosis in the iliac region, at the origin of deep femoral artery and common femoral artery was adequately perfused.The sfa was occluded completely in the distal third at the stent entrance and the popliteal artery of segment 2 was having reperfusion with then monophasic flow and pseudovenous perfusion distally with known chronic occlusion of the tibiofibular trunk with stent in place.Pseudovenous perfusion observed in the distal segment of the anterior tibial artery.Based on the symptoms and diagnostic findings, the subject was diagnosed with in-stent re-occlusion of the right sfa.Upon consultation, the subject was recommended to undergo an interventional procedure, and medications were given as a treatment for the event.Pre-interventional angiography showed diffuse wall changes in the proximal middle segment of the sfa, however freely perfused without further relevant stenosis.Later, there was an in-stent occlusion at the transition to the distal segment with reperfusion in the p2 segment.On (b)(6) 2023, 1510 days post index procedure 100% stenosis in right distal sfa along with ppa with lesion length of 250 mm and reference vessel diameter of 6 mm was treated by using a non-boston scientific thrombectomy and atherectomy device followed by balloon angioplasty.Follow up angiography showed residual stenosis.For the same, using a 6 mm x 150 mm ranger drug-coated balloon, angioplasty was performed initially.Post which, subsequent intraluminal wire probing of the anterior tibial artery up to the interdigital region with subsequent dilation, first with a 2 mm x 120 mm, then followed by 2.5 mm x 220 mm non-boston scientific balloons.In the proximal segment, 3.0 mm x 80 mm non-boston scientific balloon was used to further expand the space.Further follow up angiography revealed persistent severe stenosis in the femoropopliteal junction, so extensive balloon angioplasty was performed using 6 mm x 40 mm non-boston scientific high-pressure balloon.Finally, 6 mm x 30 mm non-boston scientific stent was implanted with post-deployment dilation.Post procedure, no complications were noted, resulting in 60% residual stenosis and no thrombus was seen.On (b)(6) 2023, duplex ultrasound on the right leg showed no ostial stenosis in the deep femoral artery with residual thrombi in the sfa without hemodynamic relevance.In popliteal segment 1, partial acoustic in-stent attenuation, moderate residual stenosis (psv 170 cm/s, pvrp 1.5), then rapidly accelerated biphasic flow was shown.No flow acceleration in the tibiofibular trunk, anterior tibial artery and fibular artery biphasic up to the distal segments.Ankle-brachial index (abi) at rest revealed 0.7 at right and 0.9 at left.Arterial doppler occlusion pressures right in mm/hg shown brachial artery at rest 135, dorsalis pedis artery at rest 90, posterior tibial artery at rest 100, fibular artery at rest 80.Electronic segment oscillography at right shown upper leg slightly pathological, calf slightly pathological, ankle slightly pathological.Final angiography shown satisfactory result with unremarkable perfusion of the femoropopliteal artery distally without evidence of severe residual stenosis.In the peri-interventional period, subject was treated by dual antiplatelet therapy with asa and clopidogrel.On (b)(6) 2023, the event was considered as recovered/resolved with sequelae and discharged on the same day with recommendation of continuing dual antiplatelet therapy permanently with 75 mg clopidogrel and rivaroxaban and follow-up appointment was scheduled on (b)(6) 2023.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17167636
• MDR Text Key: 317537985
• Report Number: 2124215-2023-31482
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: 05/26/2023
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: White