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 08/02/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier-(b)(6).Age at time of enrollment- 60 years.

Event Description

Elegance study.It was reported that in-stent restenosis occurred, requiring an additional device.The subject underwent treatment with the eluvia drug eluting stents on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), mid sfa extending to distal sfa with proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 5 mm with lesion length of 240 mm and 100 % stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment, atherectomy was performed using jetstream xc atherectomy catheter, 2.1 mm x 3 mm of non-boston scientific embolization protection device was used and pre dilation was performed with 5 mm x 120 mm sterling otw pta balloon.Treatment of target lesion was performed by placement of study devices, two eluvia drug eluting stents of 6 mm x 120 mm.The final residual stenosis was noted to be 10%.On (b)(6) 2021, the subject was discharged with clopidogrel and aspirin.On (b)(6) 2022, the subject was evaluated in the office for progressive intermittent claudication in the right leg.For that the subject underwent vs ankle branchial index procedure, which revealed ankle brachial indices with the following values with respect to atrial pressure: right brachial location resting pressure was 159 mm hg, right post tibial pressure was 69 mm hg, right dorsal pedal pressure was 66 mm hg.Based on the examination, the subject was referred for peripheral angiography as abi showed possible occlusion of previously placed stent.On (b)(6) 2022, angiography was performed which revealed, chronic total occlusion of the previously placed stent in the right sfa and chronic total occlusion to the distal sfa to proximal popliteal.On (b)(6) 2022, 427 days post index procedure, chronic total occlusion noted in the right sfa, stent was treated with drug coated balloon and the proximal end of stenosis was stented with an eluvia des.At the same time, the decision was made to perform atherectomy via 2.1 jetstream devices for total of 2 passes.Following atherectomy, angiography revealed that the flow through the distal occluded stent had significantly improved.On the same day distal sfa/proximal popliteal stenosis and recanalized stent were treated with balloon angioplasty.Aspirin 81 mg once a day and plavix 75 mg twice a day were recommended to the subject.On (b)(6) 2022, the event was considered resolved.

• 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: 15567546
• MDR Text Key: 301468416
• Report Number: 2124215-2022-39099
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027109917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2021
• 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