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); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 03/07/2023

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: the patient was 57 years old at the time of study enrollment.

Event Description

Eminent clinical study it was reported that the subject experienced stent thrombosis and restenosis in the left superficial femoral artery (sfa) 1674 days post index procedure.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 left mid sfa with 90% stenosis.The target lesion was 35 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm, and was thus classified as tasc ii a lesion.The target lesion was treated with pre-dilatation, followed by placement of a 6 mm x 40 mm study stent.Following stent placement, the lesion was post dilated, resulting in 0% final stenosis.On (b)(6) 2018, the subject was discharged.On 01-feb-2023, 1674 days post index procedure, the subject visited the hospital as follow up due to status post percutaneous transluminal angioplasty (pta) and stent implantation performed in jul-2018.During this visit, the subject complained of mild claudication of the left calf, which was clinically apparent.Doppler ultrasound performed on the left revealed severe in-stent restenosis, which was advanced.Based on the symptoms and diagnostic findings, the subject was diagnosed with re-stenosis in the stent of left sfa, which was advanced and severely narrowed.Upon consultation, the subject was recommended to undergo interventional procedure as a treatment on a later date.On 07-mar-2023, 1708 days, post index procedure, the subject was hospitalized for the planned interventional procedure.Angiography performed revealed in-stent stenosis of the left sfa.Based on the symptoms and diagnostic findings the subject was diagnosed with peripheral artery disease (pad) stage iib on the left.90% stenosis in left mid sfa with lesion length of 20 mm and reference vessel diameter of 6 mm was treated by pta followed by drug coated balloon (dcb) and implantation of 6.0 mm x 20 mm innova stent.Post procedure resulted in 5% residual stenosis and no thrombus was visualized.The procedure resulted in a good outcome and no other patient complications were reported.On (b)(6) 2023, the event was considered to be resolved and the subject was discharged on the same day with the advice of dual antiplatelet therapy with asa and clopidogrel for 3 months, then aspirin (asa) as monotherapy, while maintaining the statin with regular walking.The subject was recommended for a follow up appointment on a later date.No further patient complications were reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16941274
• MDR Text Key: 315325043
• Report Number: 2124215-2023-24286
• 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: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020370967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: White