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 10/27/2020

Event Type  Injury  

Event Description

It was reported that thrombosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2017 and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) with 95% stenosis and was 140 mm long with a proximal reference vessel diameter of 6 mm and a distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation followed by a placement of a 6 mm x 150 mm study stent.Following post dilation, 5% residual stenosis was noted.On (b)(6) 2017, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject visited the enrolling site due to pain in the right calf which began approximately 4 to 5 months previously.The intermittent claudication symptoms were particularly noted while climbing.Subject additionally had ap symptoms.Physical examination revealed easily palpable arteries at dorsalis pedis bilaterally.On the same day, the subject was admitted as an inpatient for an elective pelvic/leg angiography.On (b)(6) 2020, angiography revealed stent thrombosis in the right proximal to distal sfa which was recanalized by performing percutaneous transluminal angioplasty (pta) using a non-boston scientific 5 mm x 120 mm balloon followed by non-boston scientific 5 mm x 200 mm drug-coated balloons.Additionally, coronary angiography was also performed which revealed stenosis of d1 and lateral branch with good, unimpaired left ventricular function.On (b)(6) 2020, post procedural doppler ultrasound scan revealed good interventional results with flow velocity at the right sfa at 150 cm/s.A dual antiplatelet therapy aggregation inhibition with acetylsalicylic acid (asa) and clopidogrel was recommended for 6 months.Post 6-months, asa as a mono therapy with retention of statin was suggested.A follow-up appointment was made on (b)(6) 2021.On (b)(6) 2020, the event was considered recovered/ resolved and the subject was discharged on same day in good general condition.

Event Description

It was reported that thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2017 and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) with 95% stenosis and was 140 mm long with a proximal reference vessel diameter of 6 mm and a distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation followed by a placement of a 6 mm x 150 mm study stent.Following post dilation, 5% residual stenosis was noted.On (b)(6) 2017, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject visited the enrolling site due to pain in the right calf which began approximately 4 to 5 months previously.The intermittent claudication symptoms were particularly noted while climbing.Subject additionally had ap symptoms.Physical examination revealed easily palpable arteries at dorsalis pedis bilaterally.On the same day, the subject was admitted as an inpatient for an elective pelvic/leg angiography.On 16-nov-2020, angiography revealed stent thrombosis in the right proximal to distal sfa which was recanalized by performing percutaneous transluminal angioplasty (pta) using a non-boston scientific 5 mm x 120 mm balloon followed by non-boston scientific 5 mm x 200 mm drug-coated balloons.Additionally, coronary angiography was also performed which revealed stenosis of d1 and lateral branch with good, unimpaired left ventricular function.On (b)(6) 2020, post procedural doppler ultrasound scan revealed good interventional results with flow velocity at the right sfa at 150 cm/s.A dual antiplatelet therapy aggregation inhibition with acetylsalicylic acid (asa) and clopidogrel was recommended for 6 months.Post 6-months, asa as a mono therapy with retention of statin was suggested.A follow-up appointment was made on (b)(6) 2021.On (b)(6) 2020, the event was considered recovered/ resolved and the subject was discharged on same day in good general condition.It was further reported that on (b)(6) 2020, the subject visited the site for protocol scheduled 36-month follow-up.Additionally, over the past 6 months, the subject had noted right calf claudication symptoms at a walking distance of 200m, which was in the case of climbing earlier.Rutherford classification on the same day was at 2 (moderated claudication).Duplex ultrasound sonography performed on the same day revealed 2 highest progressive in-stent restenosis, indicative of re-intervention which was planned on a later date.In connection with recurring coronary stenosis, ezetrol 10mg was recommended.

• 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: 10927603
• MDR Text Key: 218936098
• Report Number: 2134265-2020-16696
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019834884
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHILIPS STELLAREX DRUG-COATED BALLOONS; PHILIPS STELLAREX DRUG-COATED BALLOONS; PHILIPS STELLAREX DRUG-COATED BALLOONS
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR