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 Problem Thrombosis (2100)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(6).It was reported that stent thrombosis occurred.The subject was enrolled in (b)(6) on (b)(6) 2018 and the index procedure was performed on the same day.Target lesion was located in right distal superficial femoral artery (sfa) with 99% stenosis and was 30 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 a lesion.The target lesion was treated with a direct placement of 6 mm x 40 mm study stent in the target lesion.Following post dilation, the residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, the subject was diagnosed with thrombotic occlusion in right sfa.Severe, focal stenosis in the middle segment of the right common femoral artery, extending to the partially in-stent in the right superficial femoral / popliteal artery was noted.The subject was hospitalized on the same day, for further evaluation and treatment.Pre-interventional angiography showed diffuse vessel sclerosis, severe and spindle-like stenosis in the mid area of the right common femoral artery, the stent placed in popliteal artery at the height of the second / proximal third segment was also occluded and missing contrasting of superficial femoral artery.The target lesion had a 100% stenosis and an overview angiography of the vessels of the right leg with distal subtraction angiography (dsa) technique.On (b)(6) 2020, angioplasty was performed with 6 mm x 60 mm ranger drug coated balloon (dcb) at the right common femoral artery without any significant restenosis or dissection, then the entire occluded femoropopliteal segment was treated with pre-dilatation with an 3 mm x 80 mm sterling balloon, post which the subject had a concern of noteworthy pain.Then a rotational thrombectomy was performed with the follow-up angiography showing good results.Following this, right femoropopliteal drug-coated balloon angioplasty was performed with three ranger dcb 5 mm x 150 mm to treat event.Post procedure angiography revealed mild recoil with less than 30% restenosis in the common femoral artery.During this event, rtpa lysis therapy was performed due to residual thrombi in the area of tibiofibular trunk / fibular artery, and the still occluded posterior tibial artery.On (b)(6) 2020, pre-interventional angiography showed wall irregularity near the bifurcation in the superficial femoral artery and restenosis in the distal external iliac artery.On the same day, a 35 non-bsc wire was used over the in-situ lysis catheter, followed by placement of 7 mm x 40 mm non-bsc stent, implanted into the bifurcation of the superficial femoral artery.Additionally, an 8 mm x 20 mm non-bsc stent was placed into the external iliac artery and the common femoral artery junction, and post-dilated was done for both stents with 6 mm x 20 mm non-bsc balloon, resulting in 0% final stenosis.At the time of the event, the subject was on aspirin and clopidogrel.On (b)(6) 2020, the event was considered to be recovered/resolved.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10087403
• MDR Text Key: 194772808
• Report Number: 2134265-2020-06910
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2020

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: 09/10/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021966892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention