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 Pain (1994); Thrombosis/Thrombus (4440)

Event Date 11/16/2022

Event Type  Injury  

Event Description

Eminent clinical study.It was reported there was stent occlusion.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in left mid superficial femoral artery (sfa) with 100% stenosis and was 107 mm long with a proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.7 mm and was classified as tasc ii a lesion.Target lesion was directly treated with 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.(b)(6) 2020, stent occlusion occurred in the mid-sfa.On (b)(6) 2022, 1122 days post index procedure, the subject presented for protocol scheduled 36 month follow up visit and complained of severe pain, stiffness or aching in the joints of left leg, unable to walk 1500 feet, run and unable to climb 3 flights of stairs.On arrival, rutherford category was 2 (moderate claudication).Ankle brachial index (abi) performed revealed as 0.66.Duplex ultrasound performed revealed, the common femoral artery was widely atherosclerotic with presence of multiple mild stenosis, and moderate stenosis was noted at the origin deep femoral artery.The proximal tract of the superficial femoral artery and endoprosthesis was blocked at the middle and distal tract.The event was treated medically.At the time of reporting, the event was ongoing.

• 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: 15944526
• MDR Text Key: 305139757
• Report Number: 2124215-2022-48812
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023598866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Race: White