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

Model Number 24620

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

Patient Problems Reocclusion (1985); Pain (1994); Thrombosis (2100)

Event Date 03/20/2019

Event Type  Injury  

Event Description

It was reported that in stent thrombosis and restenosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the left distal superficial femoral artery (sfa) extending in to proximal popliteal artery with 100% stenosis and was 98 mm long with a proximal reference vessel diameter of 5.80 mm and distal vessel diameter of 6.00 mm and was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation and placement of a 6 x 120 mm study stent.Following post-dilatation, residual stenosis was 25%.On (b)(6) 2016, the subject was discharged on dual antiplatelet therapy.On (b)(6) 2019, the subject visited hospital as an outpatient with the complaint of lower extremity pain.Echography was performed the same day which revealed total occlusion in the left sfa.Additionally, ankle-brachial pressure index (abi) was also done which measured abi index of 0.79 and 0.49 on right and left side respectively.The subject was scheduled for hospitalization on (b)(6) 2019 for performing further tests and treatment.On (b)(6) 2019, the subject was hospitalized and subsequently, left limb arteriography was performed which revealed 100 % thrombotic stenosis in previously placed study stent and 90% stenosis in mid sfa.100% stenosis was observed in the popliteal, anterior tibial, and posterior tibial arteries.On (b)(6) 2019, thrombectomy was performed in distal sfa to remove thrombi in study stent and stenosis in mid sfa extending to popliteal artery was treated with balloon angioplasty and deployment to two 6 x 120 mm eluvia stents.Additionally, the left tibial artery was treated with a ballooning with 25% residual stenosis.On (b)(6) 2019, abi was done again which measured 0.87 and 0.84 on right and left sides respectively.On (b)(6) 2019, the event was considered resolved and the subject was discharged on the same day.Follow-up core-lab angiography finding dated (b)(6) 2019, noted thrombus of grade 0 and absence of aneurysm.However, core lab noted the presence of in stent restenosis (isr) pattern 4.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8686948
• MDR Text Key: 147595679
• Report Number: 2134265-2019-06633
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018765486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR