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

Model Number 24620

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reocclusion (1985)

Event Date 11/09/2020

Event Type  Injury  

Event Description

It was reported that in-stent restenosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the left mid superficial femoral artery (sfa) with 90% stenosis and was 130 mm long.The target lesion had a proximal reference vessel diameter of 6.00 mm and a distal vessel diameter of 6.00 mm.It was classified as a tasc ii b lesion.The target lesion was treated with pre dilatation and placement of a 7.00 x 150 mm study stent.Following post-dilatation, the residual stenosis was 0%.On (b)(6) 2016, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject was diagnosed with restenosis in the left sfa, the left proximal popliteal artery (ppa), and the peroneal artery stasis.On (b)(6) 2020, the subject was hospitalized for further treatment and evaluation.On (b)(6) 2020, revascularization was performed by treatment of the 99% restenosis noted in the left distal sfa extending to the ppa by performing balloon angioplasty.The residual stenosis was 25%.Additionally, the left peroneal artery stasis was treated with endovascular treatment (percutaneous old balloon angioplasty).On (b)(6) 2020, the subject was discharged from the hospital.The subject was on dual antiplatelet therapy.At the time of reporting, the events were considered resolving.

Event Description

It was reported that in-stent restenosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the left mid superficial femoral artery (sfa) with 90% stenosis and was 130 mm long.The target lesion had a proximal reference vessel diameter of 6.00 mm and a distal vessel diameter of 6.00 mm.It was classified as a tasc ii b lesion.The target lesion was treated with pre dilatation and placement of a 7.00 x 150 mm study stent.Following post-dilatation, the residual stenosis was 0%.On (b)(6) 2016, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject was diagnosed with restenosis in the left sfa, the left proximal popliteal artery (ppa), and the peroneal artery stasis.On (b)(6) 2020, the subject was hospitalized for further treatment and evaluation.On (b)(6) 2020, revascularization was performed by treatment of the 99% restenosis noted in the left distal sfa extending to the ppa by performing balloon angioplasty.The residual stenosis was 25%.Additionally, the left peroneal artery stasis was treated with endovascular treatment (percutaneous old balloon angioplasty).On (b)(6) 2020, the subject was discharged from the hospital.The subject was on dual antiplatelet therapy.At the time of reporting, the events were considered resolving.It was further reported that on (b)(6) 2020, the subject presented to the hospital for regular medical examination with complaints of claudication and pain after walking approximately 200 meters.Based on these findings, the subject planned for further evaluation and treatment.On (b)(6) 2020, angiography of the left lower extremity was performed, which revealed sub-occlusion of the sfa, popliteal artery, and peroneal artery.99% stenosis noted in the left sfa was treated by performing percutaneous transluminal angioplasty using a 5.0 mm balloon.On the same day, the stenosis noted in the left popliteal artery was treated with percutaneous transluminal angioplasty by using a 4.0 mm balloon.The residual stenosis was 25%.The stenosis noted in the left peroneal artery was treated with percutaneous transluminal angioplasty by using a 2.0 mm balloon.The residual stenosis was 25%.Follow-up core-lab angiography finding dated (b)(6) 2020 noted grade 0 thrombus, absence of aneurysm, and presence of in-stent restenosis pattern 0.No stent fracture was noted; however, a radial stent deformation was noted.

• 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
• MDR Report Key: 11012030
• MDR Text Key: 221539009
• Report Number: 2134265-2020-17675
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018822222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR