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 Dyspnea (1816); Pain (1994); Dizziness (2194); Thrombosis/Thrombus (4440); Unspecified Heart Problem (4454); Restenosis (4576); Swelling/ Edema (4577)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

Patient identifier: subject (b)(6).Age at time of event: the patient was 68 years old at the time of study enrollment.

Event Description

S2444 elegance clinical study it was reported that on (b)(6) 2023, 570 days post-index procedure, the subject experienced symptoms related to stenosis in the left superficial femoral artery (sfa).Hospitalization and surgical intervention occurred in response to the event.The subject underwent treatment with three eluvia drug-eluting stents on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion #001 was in the left proximal sfa, mid sfa, extending to distal sfa.The target lesion had a proximal reference vessel diameter of 7 mm, distal reference vessel diameter of 7 mm, and a lesion length of 260 mm.The target lesion was 100% stenosed and was thus classified as a tasc ii d lesion.Prior to target lesion treatment, pre-dilation was performed using a 4 mm x 200 mm non-bsc percutaneous transluminal angioplasty (pta) balloon.Treatment of target lesion was performed by the placement of study devices; two 6 mm x 120 mm eluvia drug-eluting stents, and one 7 mm x 80 mm eluvia drug-eluting stent.Following stent placement, post-dilation was performed using 5 mm x 150 mm, and 6 mm x 80 mm sterling otw pta balloons.The final residual stenosis was noted to be 0%.The same day, the subject was discharged on dual antiplatelet therapy.On (b)(6) 2023, subject visited the clinic with complains of shortness of breath, occasional dizziness, palpitations, edema, and a burning/stinging pain in her legs.On (b)(6) 2023, 578 days post-index procedure, the subject was admitted and underwent a peripheral arteriogram in the setting of critical limb ischemia of the left lower extremity with severely reduced abi at 0.3.Due to recurrent isr (in stent restenosis), the subject needed to be evaluated by vascular surgery for possible bypass surgery.In response to the event, surgery of left sfa was performed.Post procedure, thrombus was noted, and final residual stenosis was noted to be 0%.On (b)(6) 2023, subject had a vascular consultation where the subject complained of pain in the left calf and foot, which worsened at night.The subject reported walking occasionally relieved the pain, but could also increase claudication.The subject's left foot was noted to be discolored, specifically on the plantar forefoot region.On (b)(6) 2023, the event was considered resolved and the subject was discharged from the hospital on the same day.

• 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: 17022342
• MDR Text Key: 316193297
• Report Number: 2124215-2023-25682
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027518000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ELUVIA US, 6X120, 130 CM
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Race: White