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 Obstruction/Occlusion (2422)

Event Date 03/20/2023

Event Type  Injury  

Event Description

It was reported that in-stent occlusion occurred.The subject underwent treatment with eluvia drug-eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa) and right mid sfa with proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 5 mm with lesion length of 200 mm and 100% stenosis and was classified as a tasc ii d lesion.Prior to target lesion treatment with study device, treatment was done using a 2.3 mm non-boston scientific laser followed by placement of 2 mm x 200 mm non-boston scientific bare metal stent.Treatment of target lesion was performed by placement of study device, 6 mm x 80 mm eluvia drug-eluting stent.Following post dilation was performed using 5 mm x 20 mm mustang pta balloon, and the final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged on clopidogrel.On (b)(6) 2023, during 6 month follow up, ultrasound examination revealed in-stent occlusion of the right sfa.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: age at time of event: 59 years old at the time of study 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: 17333888
• MDR Text Key: 319274908
• Report Number: 2124215-2023-37494
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0028690888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Race: Asian