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 Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 04/21/2022

Event Type  Injury  

Event Description

(b)(6) study.It was reported that in-stent restenosis occurred.The subject underwent treatment with the eluvia drug eluting stent on (b)(6) 2021 as a part of the (b)(6) trial.The target lesion was in the right mid superficial femoral artery (sfa) with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 7 mm with lesion length of 100 mm and 70 % stenosis.It was classified as a tasc ii b lesion.Prior to target lesion treatment, shockwave lithotripsy was performed.Treatment of target lesion was performed by placement of study device, eluvia drug eluting stent of 7mm x 120 mm.Following post dilation with 7 mm x 100 mm and 7 mm x 60 mm sterling pta balloons, the final residual stenosis was noted to be 20%.On the same day, the subject was discharged with clopidogrel and aspirin.On (b)(6) 2022, subject visited the hospital for study specific 6 month follow up.Subsequently, lower arterial duplex was performed which revealed 75-99% stenosis in right common femoral artery, very poor monophasic flow in right sfa stent suggestive of severe disease and occlusion of tibial artery.On (b)(6) 2022, subject revisited hospital with the complaints of severe right lower extremity lifestyle limiting claudication and was referred for an angiography with possible intervention.On the same day, pre-operative abi performed revealed 1.04 and 1.03 on right and left leg respectively and rutherford category of 3 (severe claudication).Subsequently angiography was performed which revealed the following in the right lower extremity: patent common iliac artery, tortuous with moderate diffuse disease of external iliac artery, patent internal iliac artery, common femoral artery and profunda femoral artery, severe focal stenosis at the proximal edge of previously placed mid sfa stent.On (b)(6) 2022, 181 days post index procedure, 80% stenosis noted at the proximal edge of right mid sfa stent was treated with percutaneous transluminal angioplasty using 6.0 mm x 20 mm non-boston scientific balloon followed by placement of 7.0 mm x 40 mm eluvia drug eluting stent.Following post dilation with 7.0 mm x 40 mm non-boston scientific balloon, the final stenosis was noted to be 5%.Additionally, severe stenosis noted in the right common femoral artery was treated with directional atherectomy followed by balloon dilation with 7.0 mm x 40 mm non-boston scientific drug coated balloon with excellent angiographic results.On (b)(6) 2022, the event was considered resolved.

Manufacturer Narrative

Patient identifier: (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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14522648
• MDR Text Key: 292967270
• Report Number: 2134265-2022-06029
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027577877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White