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/Thrombus (4440)

Event Date 07/13/2022

Event Type  Injury  

Event Description

Eminent study.It was reported that thrombosis 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 proximal superficial femoral artery (sfa) with 75% stenosis and was 30 mm long with a proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 6.0 mm and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation, followed by 6 mm x 60 mm study stent was placed.Post dilatation was performed with final residual stenosis of 10%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1524 days post index procedure, the subject presented with unknown symptoms and was diagnosed with in-stent thrombosis.The subject was recommended to undergo interventional procedure as a treatment for this event.The in-stent thrombosis was treated with thrombectomy, percutaneous transluminal angioplasty using drug coated balloon and stent implantation was performed.On (b)(6) 2022, the event was considered recovered/resolved.

Manufacturer Narrative

(b)(6).Age at time of event: 64 years.(b)(6).

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15184558
• MDR Text Key: 297445820
• Report Number: 2124215-2022-28876
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P180011
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021516894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White