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 Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 05/02/2022

Event Type  Injury  

Event Description

Eminent clinical study.It was reported that an in-stent restenosis 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 the proximal popliteal artery.The lesion was 100% stenosed, 100mm long, with a proximal reference vessel diameter of 5mm and distal vessel diameter of 5mm, and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation, followed by placement of 6mm x 120mm eluvia drug eluting study stent.Post dilatation was performed with final residual stenosis of 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1079 days post index procedure, the subject was presented for a 36 month follow up and complained of claudication symptoms in the right calf when walking a distance of approximately 500 meters.The rutherford criteria was classified as 2 (moderate claudication).Ankle-brachial index (abi) on the right revealed 0.67 and 1.08 on the left.The duplex ultrasound report showed biphasic common femoral artery, sever stenosis visible in proximal sfa stent, monophasic perfusion of the popliteal artery in the right.Based on the symptoms and diagnostic findings, the subject was diagnosed with high grade in-stent stenosis of the right sfa.The subject was recommended to undergo surgical interventional procedure on a later date.On (b)(6) 2022, 1105 days post index procedure, the subject presented with symptoms of repeat claudication on the right with a pain free walking distance of approximately 500 meters and these pains are impairing the day to day life.Treadmill test revealed pains start all over the right leg (initial claudication distance) after only 21 meters and stopped because of a severe increase in pains at 48 meters (maximum claudication distance).The subject was hospitalized for further treatment and evaluation.Selective angiography performed on the same day revealed severe stenosis of the in-stent stenosis in the distal section of the sfa with a two vessel runoff via the anterior tibial artery and fibular artery.On (b)(6) 2022, 1105 days post index procedure, 90% stenosis in the right distal sfa (target lesion) with lesion length of 70mm and reference vessel diameter of 6mm was treated with percutaneous transluminal angioplasty using a 5mm x 120mm mustang balloon and a 6mm x 80mm luminor drug eluting balloon.Post treatment revealed, 5% residual stenosis.There were no complications and thrombus noted.On the same day the event was considered resolved.On (b)(6) 2022, doppler ultrasound performed revealed, no evidence of a pseudoaneurysm, dissection or av fistula and strong biphasic perfusion of the common femoral artery up to the offsets of the deep femoral artery and superficial artery.Abi on the right revealed 0.9.The patient was discharged with the advice of antiplatelet therapy as permanent for four weeks post intervention.

• 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: 14548054
• MDR Text Key: 292975016
• Report Number: 2134265-2022-06063
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023144488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: White