MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24657

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440)

Event Date 08/31/2023

Event Type  Injury  

Event Description

Elegance clinical study.It was reported that in-stent occlusion occurred.The subject underwent treatment with the eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion #001 was in the left proximal superficial femoral artery, left mid superficial femoral artery extending up to left distal superficial femoral artery with 5.5 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length of 300 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using 5.0 mm x 2.00 mm non-bsc balloon.Treatment of target lesion was performed by the placement of three 6.0 mm x 120 mm eluvia drug eluting stents study devices.Following post treatment, dilation was performed by using 5.0 mm x 200 mm non-bsc balloon, and the final residual stenosis was noted to be 10%.On (b)(6) 2023, the subject visited the emergency room with complaints of new onset of pain in the left lower extremities.On examination, left lower extremity signals were absent.On the same day, computed tomography angiography (cta) performed revealed complete occlusion of the left superficial femoral artery stent with distal reconstitution of flow at the origin of the popliteal artery secondary to collateral flow and three vessel runoffs of the right lower extremity to the level of foot.Based on the findings, subject was transferred to other hospital for peripheral intervention.On arrival, subject was hospitalized for further medical treatment.On (b)(6) 2023, 143 days post index procedure, in-stent thrombotic occlusion noted in the left proximal superficial femoral artery, left mid superficial femoral artery extending up to left distal superficial femoral artery was treated by thrombolysis using 1mg/hr tpa infusion via ekos catheter.On (b)(6) 2023, angiogram performed revealed patent left sfa stents with moderate ostial sfa stenosis.Per edc, (b)(6) 2023, the event was considered to be resolved.On (b)(6) 2023, the subject was discharged from the hospital.

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: 45 years old at the time of enrollment.

• 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: 18102490
• MDR Text Key: 327750926
• Report Number: 2124215-2023-58786
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030030416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Hispanic