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

Model Number 24653

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

Patient Problems Occlusion (1984); Claudication (2550)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) study.It was reported that in-stent occlusion occurred.The subject underwent treatment with a study device on (b)(6) 2017 as part of the eminent clinical trial.The target lesion was located in the right distal superficial femoral artery (sfa) involving ppa with 100% stenosis.The lesion was 70 mm long with a proximal reference vessel diameter of 5 mm and a distal reference vessel diameter of 5mm and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation followed by placement of the 6 mm x 100 mm stent.Following post dilation, residual stenosis was 0%.On december 04, 2017, the subject was discharged on antiplatelet therapy.On (b)(6) 2019, in-stent occlusion of the right sfa.On (b)(6) 2019, the subject developed in-stent occlusion in the right sfa including the p1 segment of the popliteal artery.On the same day, the subject was hospitalized for further evaluation and treatment.On an unknown date, the subject underwent femoral popliteal artery bypass surgery as a treatment for this event.On (b)(6) 2019, the event was considered to be recovered/resolved and the subject was discharged on the same day.

Manufacturer Narrative

Patient identifier: (b)(6).Initial reporter facility name: klinikum rosenheim institut fur diagnostische und interventi.

Event Description

Eminent clinical study.It was reported that in-stent occlusion occurred.The subject underwent treatment with a study device on (b)(6) 2017 as part of the eminent clinical trial.The target lesion was located in the right distal superficial femoral artery (sfa) involving ppa with 100% stenosis.The lesion was 70 mm long with a proximal reference vessel diameter of 5 mm and a distal reference vessel diameter of 5mm and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation followed by placement of the 6 mm x 100 mm stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2017, the subject was discharged on antiplatelet therapy.On (b)(6) 2019, in-stent occlusion of the right sfa.On (b)(6) 2019, the subject developed in-stent occlusion in the right sfa including the p1 segment of the popliteal artery.On the same day, the subject was hospitalized for further evaluation and treatment.On an unknown date, the subject underwent femoral popliteal artery bypass surgery as a treatment for this event.On (b)(6) 2019, the event was considered to be recovered/resolved and the subject was discharged on the same day.It was further reported that on (b)(6) 2019, aortic arteriography was performed that confirmed an in-stent repeat occlusion on the right side.Based on the findings, subject was diagnosed with in-stent occlusion of the right distal sfa through to the popliteal level.Re-intervention was recommended.(b)(6) 2019, the subject was hospitalized for planned intervention and had chief complaints of limited walking restriction with typical calf claudication on the right.The subject had post percutaneous transluminal angioplasty (pta) and stent implantation of the right femoral popliteal artery in april 2016 and an unsuccessful recanalization attempt due to stent occlusion in (b)(6) 2019.As the subject had two unsuccessful attempts at interventional recanalization, the consultant recommended intervention through the femorpopliteal p3 venous bypass.On (b)(6) 2019, the subject underwent femoral popliteal artery bypass surgery as a treatment for this event.It was further reported that the unsuccessful recanalization attempt made in (b)(6) 2019 was not due to stent occlusion.Stent occlusion was first seen in (b)(6) 2019 and was treated in (b)(6) 2019.

Manufacturer Narrative

Patient identifier: (b)(6).Initial reporter facility name: (b)(6).

Event Description

Eminent clinical study: it was reported that in-stent occlusion occurred.The subject underwent treatment with a study device on (b)(6) 2017 as part of the eminent clinical trial.The target lesion was located in the right distal superficial femoral artery (sfa) involving ppa with 100% stenosis.The lesion was 70 mm long with a proximal reference vessel diameter of 5 mm and a distal reference vessel diameter of 5mm and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation followed by placement of the 6 mm x 100 mm stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2017, the subject was discharged on antiplatelet therapy.On (b)(6) 2019, in-stent occlusion of the right sfa.On (b)(6) 2019, the subject developed in-stent occlusion in the right sfa including the p1 segment of the popliteal artery.On the same day, the subject was hospitalized for further evaluation and treatment.On an unknown date, the subject underwent femoral popliteal artery bypass surgery as a treatment for this event.On (b)(6) 2019, the event was considered to be recovered/resolved and the subject was discharged on the same day.It was further reported that on (b)(6) 2019, aortic arteriography was performed that confirmed an in-stent repeat occlusion on the right side.Based on the findings, subject was diagnosed with in-stent occlusion of the right distal sfa through to the popliteal level.Re-intervention was recommended.(b)(6) 2019, the subject was hospitalized for planned intervention and had chief complaints of limited walking restriction with typical calf claudication on the right.The subject had post percutaneous transluminal angioplasty (pta) and stent implantation of the right femoral popliteal artery in (b)(6) 2016 and an unsuccessful recanalization attempt due to stent occlusion in (b)(6) 2019.As the subject had two unsuccessful attempts at interventional recanalization, the consultant recommended intervention through the femorpopliteal p3 venous bypass.On (b)(6) 2019, the subject underwent femoral popliteal artery bypass surgery as a treatment for this event.

• 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
• MDR Report Key: 10740414
• MDR Text Key: 213200320
• Report Number: 2134265-2020-14805
• 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,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019635396
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR