MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Obstruction/Occlusion (2422)

Event Date 09/01/2016

Event Type  Injury  

Event Description

It was reported via journal article that occlusion occurred.Abstract: the fluoropolymer-coated, paclitaxel-eluting eluvia stent has shown promising results for the endovascular treatment of femoropopliteal artery lesions in patients with claudication.The aim of the current study was to evaluate efficacy and safety outcomes of the eluvia stent for the treatment of long femoropopliteal lesions in asian patients.This is a single center, retrospective study.The primary endpoint was primary patency at 1 year.Secondary outcomes were 30-days complication rate, technical success, 1-year freedom from clinically driven target lesion revascularization (cd-tlr), limb salvage, survival, amputation-free survival (afs), wound healing, and clinical improvement.A total of 64 patients with 67 femoropopliteal lesions were included; 78% suffered from diabetes and 84% had chronic limb-threatening ischemia (clti).Of those with ischemic wounds, 79% did not have run-off to the foot.Mean lesion length was 193 plus or minus 128 mm and 52% were severely calcified.Primary patency at 1 year was 84% in the overall cohort and 91% in patients with complete lesion coverage with the eluvia stent.Technical success was achieved in 100% of the cases and 30-day complications occurred in six patients.Twelve-month freedom from cd-tlr, limb salvage, survival, and afs were 92%, 93%, 85%, and 80%, respectively.In 80% of patients, complete wound healing was experienced and 84% had clinical improvement after 1 year.The eluvia stent showed promising 12-month patency and clinical results for femoropopliteal treatment in this clti-dominant patient population with severely calcified, long lesions.Patient numbers were, however, small; larger trials are required to validate these findings.Aneurysmal change seen in some cases also needs further investigation.Results: a total of 64 patients were enrolled in the study with a mean age of 70 plus or minus 12 years.A total of 67 fp lesions were treated with 146 eluvia stents.Three patients had bilateral treatment.Rutherford category 4 or 5 (i.E., clti) accounted for 84% of the limbs.Mean lesion length was 193 plus or minus 128 mm; 48% of the lesions were occlusions and 52% were severely calcified according to the peripheral academic research consortium (parc) classification.Before revascularization, 60% of the patients had 0 or 1 tibial run-off vessels.Three patients developed visible absence of wall apposition to the stent exceeding the diameter of the stent.Two of these were detected at 5 and 20 months postintervention and were occluded.The other one was asymptomatic and diagnosed at 22 months after the procedure.This patient refused intervention at the time of follow-up.

Manufacturer Narrative

Initial reporter facility name: (b)(6).Steven kum1, jetty ipema2, eline huizing2, yih k tan1, darryl lim1, ian yh lok3, constantijn evb hazenberg4 and cagdas unlu2.Outcomes of the paclitaxel-eluting eluvia stent for long femoropopliteal lesions in asian patients with predominantly chronic limb-threatening ischemia.Vascular medicine, 2021, vol.26(3) 267-272.

• Brand Name: ELUVIATM 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15411245
• MDR Text Key: 299777826
• Report Number: 2124215-2022-35618
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other