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); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)

Event Date 12/14/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier - (b)(6).Age at time of event - the patient was 79 years old at the time of study enrollment.

Event Description

(b)(6) clinical study: it was reported that stent thrombosis occurred 1296 days post index procedure.The subject was enrolled in the (b)(6) study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in right distal superficial femoral artery (sfa) and involving the proximal popliteal artery with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation, followed by a placement of an eluvia eu, 6x80, 130 cm 6 mm x 80 mm.Following post dilatation, residual stenosis was 15%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1296 days post index procedure, the patient presented with an unknown symptom and was diagnosed with stent thrombosis.No action was taken to treat the event at the time.However, the patient was recommended to be hospitalized to undergo revascularization as a treatment for this event at a later date.

Manufacturer Narrative

A1: patient identifier - (b)(6).A2: age at time of event - the patient was 79 years old at the time of study enrollment.

Event Description

Eminent clinical study.It was reported that stent thrombosis of the distal superficial femoral artery (sfa) and proximal popliteal artery occurred 1296 days post index procedure.On (b)(6) 2019, the patient was enrolled in the eminent study and the index procedure was performed on the same day.The target lesion was located in right distal sfa and involving the proximal popliteal artery with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation, followed by placement of an eluvia eu, 6x80, 130 cm 6 mm x 80 mm.Following post dilatation, residual stenosis was noted to be 15%.On (b)(6) 2019, the patient was discharged with antiplatelet therapy.On (b)(6) 2022, 1296 days post index procedure, the patient presented with pain in the right calf for three to four days prior and walking distance was currently significantly below 200 meters.Clinical examination showed only inguinal pulses were palpable on right side.The patient was diagnosed with stent thrombosis of the right distal sfa and proximal popliteal artery.On the same day, duplex examination performed revealed new stenoses in the middle third of sfa.The stent in the p1 segment appeared to be occluded.Downstream popliteal artery was patent with monophasic/distended biphasic signal.Based on the findings, the patient was diagnosed with peripheral arterial occlusive disease, currently stage iib due to subacute stent thrombosis of the right p1 segment.No action was taken to treat the event at the time.However, the patient was recommended to be hospitalized to undergo revascularization as a treatment for this event at a later date.On (b)(6) 2023, 1317 days post index procedure, the patient presented to the clinic with pain in the right calf with calf claudication after walking approximately 150 meters.On the same day, the patient was admitted for the planned interventional procedure.Upon clinical examination, a strong inguinal pulse was palpated on both sides and further peripheral pulses were not palpable.Doppler index performed on the same day revealed 0.39 on the right leg.On (b)(6) 2023, 1318 days post index procedure, the patient underwent treatment for the stent thrombosis of the right distal sfa and proximal popliteal artery.The target lesion was reportedly 100% stenosed with thrombus, with a 5 mm reference vessel diameter and 87 mm lesion length.An antegrade digital subtraction angiography rotational thrombectomy/atherectomy was performed using a non-bsc device.After multiple passes with the atherectomy device, the stent appeared largely patent, with moderate edge stenosis proximally and severe distally.Percutaneous transluminal angioplasty was performed using a non-bsc drug coated balloon.Post procedure, there was 15% residual stenosis, and no thrombus was seen.Additionally, increased doppler index of 0.9 was seen on the right and a strong dorsalis pedis pulse was now palpable on the right.Upon ultrasound examination, the patient was noted with small pseudoaneurysm.However, as the patient had no symptoms in the context of the pseudoaneurysm, a conservative treatment with pressure bandages was applied here, which made the pseudoaneurysm easily compressible.On (b)(6) 2023, the event was considered to be resolved and the patient was discharged on the same day.No further patient complications were reported.It was further reported that on (b)(6) 2022, 1292 days post index procedure, the patient experienced pain in the right calf.

• 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: 16146210
• MDR Text Key: 307173976
• Report Number: 2124215-2022-56154
• 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,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023454024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female