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 Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 08/11/2023

Event Type  Injury  

Manufacturer Narrative

A2: age at time of event: 72 years old at the time of study enrollment.

Event Description

Eminent clinical study.It was reported that in-stent occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2018, and the index procedure was performed on the same day.The target lesion was located in the right ostial, proximal and mid superficial femoral artery (sfa) with 100% stenosis and was 180 mm long with a proximal reference vessel diameter of 5.7 mm and a distal reference vessel diameter of 4.1 mm.It was classified as a tasc ii c lesion.The target lesion was treated with pre-dilatation and followed by placement of two 6 mm x 120 mm study stents.Post treatment, a dissection was noted, hence 5 mm x 100 mm and 4 mm x 100 mm two stents were implanted.Following post dilation, residual stenosis was 25%.On (b)(6) 2018, the subject was discharged.On (b)(6) 2023, 1758 days post index procedure, the subject presented to hospital with increase in symptoms in both the legs.On the same day, eai caused significantly decreased symptoms.However, echography performed was not clear whether there was concern for a new thrombus.Ankle knee pressure on both legs was performed and the right leg showed [r]=2.1 (was 2.3) at 25 cm, and [r]=2.2 (was 2.3) at 16 cm above the patella and [r]=2.8 in the popliteal artery, followed by monophasic signal in the popliteal artery and the trunk.At the origin of sfa, the stent was open and then the entire stent was closed.On (b)(6) 2023, doppler was performed for both legs on the great saphenous vein (gsv) and short saphenous vein (ssv).Based on the symptoms, the subject was diagnosed with occlusion in the entire right sfa.On (b)(6) 2023, the subject was recommended to undergo fem-p3 bypass surgery.However, the subject was not keen to undergo surgery, so it was suggested to first try more supervised walking therapy and the subject was followed up by the site through telephone communication regarding the therapy for 2 months.At the end of visit, subject was recommended to take acenocoumarin 1 mg tablet in the evening after the meal and clopidogrel 75mg tablet 1 for day.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18094311
• MDR Text Key: 327657757
• Report Number: 2124215-2023-62736
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022326837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Race: White