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 Problem Thrombosis (2100)

Event Date 04/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) clinical study.It was reported that stent thrombosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2017 and the index procedure was performed on the same day.Target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis and was 80mm long with a proximal reference vessel diameter of 6mm and distal reference vessel diameter of 6mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilation followed by placement of a 6 mm x 100 mm study stent in the target lesion.Following post dilation, the residual stenosis was 0%.On (b)(6) 2017, the subject was discharged with antiplatelet therapy.On (b)(6) 2019, total occlusion of implanted stent right sfa.On (b)(6) 2020, the subject developed thrombosis in right sfa stent.On (b)(6) 2020, the subject was hospitalized for further evaluation and treatment.On (b)(6) 2020, 100% stenosis in the right mid sfa which was 320 mm long with a reference vessel diameter of 6 mm was treated with lysis therapy.Following this, percutaneous transluminal angioplasty was performed using drug eluting balloons (deb).Post ballooning, dissection was noted in the proximal right sfa which was treated with stent implantation.Post treatment, final stenosis was 20%, with no thrombus.On (b)(6) 2020, the event was considered recovered/resolved, and the subject was discharged on the same day.

Event Description

Eminent clinical study: it was reported that stent thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2017 and the index procedure was performed on the same day.Target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis and was 80mm long with a proximal reference vessel diameter of 6mm and distal reference vessel diameter of 6mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilation followed by placement of a 6 mm x 100 mm study stent in the target lesion.Following post dilation, the residual stenosis was 0%.On (b)(6) 2017, the subject was discharged with antiplatelet therapy.On (b)(6) 2019, total occlusion of implanted stent right sfa.On (b)(6) 2020, the subject developed thrombosis in right sfa stent.On (b)(6) 2020, the subject was hospitalized for further evaluation and treatment.On (b)(6) 2020, 100% stenosis in the right mid sfa which was 320 mm long with a reference vessel diameter of 6 mm was treated with lysis therapy.Following this, percutaneous transluminal angioplasty was performed using drug eluting balloons (deb).Post ballooning, dissection was noted in the proximal right sfa which was treated with stent implantation.Post treatment, final stenosis was 20%, with no thrombus.On (b)(6) 2020, the event was considered recovered/resolved, and the subject was discharged on the same day.It was further reported that: on (b)(6) 2020, the subject developed symptoms of intermittent pain at rest with feeling of numbness in right leg.On (b)(6) 2020, upon physical examination, the right leg was noted to be cooler in the forefoot area with clearly slowed recapillarization time.On arrival, the subjects peripheral arterial occlusive disease (paod) stage was iii.The doppler index was 0 on the right and 1 on the left.Duplex sonography of the right leg revealed sfa with short stub and then occluded until recontrasting in pii segment with monophasic signal.The subject had subacute ischemia on the right in connection with suspected fresh stent occlusion in the right sfa.Computer tomography of the pelvic and leg vessels with contrast medium revealed newly occurring occlusion of the sfa on the right.On (b)(6) 2020, a 20 cm non-boston scientific lysis catheter was inserted in the right sfa and lysis therapy was initiated.On (b)(6) 2020, 100% stenosis in the target lesion, which was 320 mm long with a reference vessel diameter of 6 mm, was treated with lysis therapy using a 20 cm non-boston scientific lysis catheter.Post lysis control, in the area of the proximal sfa, residual thrombosis was seen.The proximal and distal parts of the implanted non-boston scientific stent graft showed edge stenosis that probably led the underlying lesion to a thrombosis of the stent; therefore, lysis therapy was continued.On (b)(6) 2020, additional core lab angiography revealed not patent outflow with unknown status of inflow and in-stent restenosis pattern; however, no thrombus or aneurysm was noted.Also, the study stent was completely covered with a non-boston scientific stent graft (250mm), which was placed in the first reangio.Restenosis at the edges of the stent graft was present however, stent inside the stent graft was patent, and the study stent was completely occluded in the first reangio report.On (b)(6) 2020, edge stenosis of the proximal stent end in the right sfa was treated with 5 mm x 80 mm percutaneous transluminal angioplasty (pta).Post pta, edge stenosis was treated with a 6 x 80 mm non-boston scientific drug coated balloon initially and then followed by a 6 x 40 mm non-boston scientific drug coated balloon dilatation in the distal edge stenosis was performed.Later, proximal to the non-boston scientific stent graft, a dissection in the non-stented vessel was noted, which was treated by a placement of an non-boston scientific stent.On (b)(6) 2020, the event was considered recovered/ resolved, and the subject was discharged on the same day with aspirin and clopidogrel.

Manufacturer Narrative

Patient identifier: (b)(6).Initial reporter address 1: (b)(6).

• 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: 10046714
• MDR Text Key: 190619666
• Report Number: 2134265-2020-06284
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020330963
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR