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); Restenosis (4576)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) clinical study: it was reported there was in-stent thrombosis.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 right distal superficial femoral artery (sfa) involving proximal popliteal artery with 100% stenosis and was 140 mm long with a proximal reference vessel diameter of 5.5 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 6 mm x 120 mm and 6 mm x 60 mm.Following post dilation, residual stenosis was 20%, hence a 6 mm x 40 mm study stent was used.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1105 days post-index procedure, the subject presented with acute pain and numbness in the right foot.On the same day, the subject was hospitalized and underwent a revascularization procedure as a treatment for this event.General findings of extremities showed no edema or varices.Pre-interventional angiography of the right leg revealed repeat multilayered complete occlusion in the distal segment of superficial femoral artery stent, and native reperfusion in the p3 segment.The color-coded duplex ultrasound revealed acute in-stent repeat occlusion of the distal superficial femoral artery on the right through to the distal popliteal artery with presentation of many small caliber collateral vessels over the course.The subject was diagnosed with peripheral arterial occlusive disease (paod) stage fontaine iv clinical symptoms and thrombotic re-occlusion of sfa and apop i on the right side.Treatment on (b)(6) 2022 was for 100% stenosis from right proximal to distal sfa involving popliteal artery (target lesion) with 200 mm lesion length and a 6 mm reference vessel diameter.Recanalization was performed with 6f rotarex rotational thrombectomy for re-establishment of the flow.However, there was an evidence of residual thrombi in-stent in the superficial femoral artery, for which the dilation was performed with 6 mm x 20 mm sterling balloon and a 6 mm x 40 mm zilver ptx stent was implanted.Additionally, 6 mm x 40 mm ranger balloon was used for dilation of a moderate to high-grade in-stent restenosis in the popliteal artery.Post treatment, final angiography showed good outcome with two vessel lower leg supply without higher-grade stenosis, resulting into 10% residual stenosis, and no thrombus was seen (per edc).On (b)(6) 2022, color-coded duplex ultrasound revealed no bleeding and superficial femoral artery with strong monophasic perfusion over the entire course.On (b)(6) 2022, the event was considered recovered/resolved and the subject was discharged on the same day with recommendation to continue antiplatelet therapy with clopidogrel for 6 months, 15 mg rivaroxaban twice a day for 3 weeks.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14411840
• MDR Text Key: 291807276
• Report Number: 2134265-2022-04718
• 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• 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: 04/20/2022
• 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; Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White