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 Thrombosis (2100); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: subject was (b)(6) at the time of enrollment.(b)(6).

Event Description

(b)(6).It was reported that in-stent 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 the popliteal artery with 100% stenosis and was 140 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm.It was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation followed by direct placement of 7 mm x 100 mm and 7 mm x 80 mm study stents.Following post dilation, residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, the subject presented with one day persistent pain below the knee, coldness and numbness in the fore foot of the right leg and was hospitalized for further evaluation and treatment.Ultrasound revealed thrombotic occlusion of the stent in target lesion without evidence of stenosis.On the same day, lysis was performed with actilyse 60 mg/24 h via the 4f lysis catheter in place to treat 20 cm length in right distal sfa the event.On (b)(6) 2020, arteriography of the right leg revealed functional imaging in flexion without evidence of stent collapse or bending in the bordering second and third popliteal segments in the context of status post femoropopliteal stent implantation.The event was considered recovered/resolved and the subject was discharged on the on aspirin.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: age at time of event: subject was 77 years old at the time of enrollment.E1: initial reporter facility name: (b)(6).

Event Description

Eminent clinical study.It was reported that in-stent 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 the popliteal artery with 100% stenosis and was 140 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm.It was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation followed by direct placement of 7 mm x 100 mm and 7 mm x 80 mm study stents.Following post dilation, residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, the subject presented with one day persistent pain below the knee, coldness and numbness in the fore foot of the right leg and was hospitalized for further evaluation and treatment.Ultrasound revealed thrombotic occlusion of the stent in target lesion without evidence of stenosis.On the same day, lysis was performed with actilyse 60 mg/24 h via the 4f lysis catheter in place to treat 20 cm length in right distal sfa the event.On (b)(6) 2020, arteriography of the right leg revealed functional imaging in flexion without evidence of stent collapse or bending in the bordering second and third popliteal segments in the context of status post femoropopliteal stent implantation.The event was considered recovered/resolved and the subject was discharged on the on aspirin.It was further reported that on (b)(6) 2019, baseline core lab angiography performed in distal sfa involving ppa of the right limb revealed severe calcification with absence of thrombus, ulceration and aneurysm and there was no inflow tract patency noted.On (b)(6) 2020 the persistent pain below the knee was occurring after squatting for a long period of time.The subject had stage iib peripheral arterial occlusive disease on both legs.An additional angiography core lab revealed patent outflow and inflow remained unknown, with occlusive in-stent restenosis pattern, with presence of thrombus and absence of aneurysm.Of note, 98% stenosis was noted in the target lesion.Post treatment, normal perfusion of the right distal femoropopliteal flow, as well as triple-vessel flow at the lower leg on right, was noted with final residual stenosis of 0%.

• 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
• MDR Report Key: 10115261
• MDR Text Key: 194773114
• Report Number: 2134265-2020-07426
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020986452
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• Patient Sequence Number: 1
• Treatment: ELUVIA 70X100X75; ELUVIA 70X100X75
• Patient Outcome(s): Hospitalization; Required Intervention