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 Pain (1994); Thrombosis/Thrombus (4440)

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

Age at time of event: (b)(6) at time of enrollment.

Event Description

(b)(6).It was reported that stent thrombosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2019.Target lesion was located in right mid sfa with 100% stenosis and was 79 mm long with a proximal reference vessel diameter of 4.76 mm and distal reference vessel diameter of 4.82 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilatation, followed by placement of a 6 mm x 100 mm eluvia drug-eluting vascular stent system.Following post dilation, residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1078 days post index procedure, the subject presented to the protocol scheduled 36 month follow up visit and duplex ultrasound was performed which revealed in-stent re-occlusion of sfa in the right limb.On (b)(6) 2022, as a part of follow up, the subject re-visited with symptoms of slight pain in the right limb and severe difficulty in walking.No action was taken to treat the event; however, revascularization has been planned to perform on a later date.At the time of reporting, the event was ongoing.

Event Description

(b)(6).It was reported that stent thrombosis occurred.The subject was enrolled in the eminent study on (b)(6), 2019.Target lesion was located in right mid superficial femoral artery (sfa) with 100% stenosis and was 79 mm long with a proximal reference vessel diameter of 4.76 mm and distal reference vessel diameter of 4.82 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilatation, followed by placement of a 6 mm x 100 mm eluvia drug-eluting vascular stent system.Following post dilation, residual stenosis was 0%.On (b)(6), 2019, the subject was discharged with antiplatelet therapy.On (b)(6), 2022, 1078 days post index procedure, the subject presented to the protocol scheduled 36 month follow up visit and duplex ultrasound was performed which revealed in-stent re-occlusion of sfa in the right limb.On (b)(6), 2022, as a part of follow up, the subject re-visited with symptoms of slight pain in the right limb and severe difficulty in walking.No action was taken to treat the event; however, revascularization has been planned to perform on a later date.It was further reported that on (b)(6), 2022, the subject presented due to pain in right leg.On the same day, duplex ultrasound was performed which revealed extensive occlusion of the right superficial femoral artery (sfa) over the entire thigh.There is a short section of residually perfused vascular stump with an attack curve at the origin of the sfa.The indwelling stent in the middle and distal thirds of the sfa is completely occluded.Pathological monophasic refill curve in the popliteal artery with significantly reduced flow rates of up to 22 cm/s.The subject was diagnosed with in-stent re-occlusion of sfa in the right limb.On (b)(6), 2022, the subject was hospitalized due to stage iib paod on the right for planned lysis of the sfa on the right.On the same day, initial angiography performed revealed in line with the ultrasound, a long section of occlusion of almost the entire sfa on the right is observed after a residual stump of 0.7 cm including the distal sfa stenting.Refilling of the femoropopliteal junction directly at the distal stent end.There is strong-caliber triple-vessel outflow at the lower leg, but with an occlusion at the junction between the distal posterior tibial artery and the plantar artery.For the same, fibrinolysis was performed with initial fractionated infiltration of the entire occlusion with a total of 4 mg of actilyse of the right sfa.Subject had uncomplicated procedure and advised to continuation of local lysis according to plan and duplex angiography on the next day.On (b)(6), 2022, angiography performed revealed right superficial femoral artery was recanalized 22 hours after starting lysis, however several severe stenosis in the proximal segment, mild stenosis in the middle segment, and severe in-stent stenosis are observed also there are moderate and severe stenosis at the distal end of the stent at the femoropopliteal junction.On dsa performed with a bent knee, the stent in the distal superficial femoral artery (sfa) and popliteal artery were freely perfused without loop formation.On (b)(6), 2022, the target lesion with 90% stenosis was treated by performing in the proximal right sfa and in distal sfa using 6 mm x 80 mm balloon.Despite of prolonged balloon pta of the proximal sfa and the site of the proximal occlusion at the start of lysis, there are moderate and high-grade residual stenosis noted, hence a 7 mm x 40 mm self-expanding non-boston scientific stent was implanted.Finally, post dilatation was performed using a 6 mm x 40 mm balloon.Post intervention angiography revealed rapid inflow into the lower leg arteries and pedal arteries.No new thromboembolic event was seen.Angio morphology showed uncomplicated surgery with good outcome.On (b)(6), 2022, the event was considered to be resolved.On (b)(6), 2022, the subject was discharged with the recommendation of aspirin 100 mg as a permanent therapy and clopidogrel 75 mg for six weeks.

Manufacturer Narrative

A2 - age at time of event: 61 years old at time of enrollment.

Manufacturer Narrative

A2 - age at time of event: 61 years old at time of enrollment.

Event Description

Eminent study.It was reported that stent thrombosis occurred.The subject was enrolled in the eminent study on (b)(6), 2019.Target lesion was located in right mid superficial femoral artery (sfa) with 100% stenosis and was 79 mm long with a proximal reference vessel diameter of 4.76 mm and distal reference vessel diameter of 4.82 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilatation, followed by placement of a 6 mm x 100 mm eluvia drug-eluting vascular stent system.Following post dilation, residual stenosis was 0%.On (b)(6), 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1078 days post index procedure, the subject presented to the protocol scheduled 36 month follow up visit and duplex ultrasound was performed which revealed in-stent re-occlusion of sfa in the right limb.On (b)(6), 2022, as a part of follow up, the subject re-visited with symptoms of slight pain in the right limb and severe difficulty in walking.No action was taken to treat the event; however, revascularization has been planned to perform on a later date.It was further reported that on (b)(6), 2022, the subject presented due to pain in right leg.On the same day, duplex ultrasound was performed which revealed extensive occlusion of the right superficial femoral artery (sfa) over the entire thigh.There is a short section of residually perfused vascular stump with an attack curve at the origin of the sfa.The indwelling stent in the middle and distal thirds of the sfa is completely occluded.Pathological monophasic refill curve in the popliteal artery with significantly reduced flow rates of up to 22 cm/s.The subject was diagnosed with in-stent re-occlusion of sfa in the right limb.On (b)(6), 2022, the subject was hospitalized due to stage iib paod on the right for planned lysis of the sfa on the right.On the same day, initial angiography performed revealed in line with the ultrasound, a long section of occlusion of almost the entire sfa on the right is observed after a residual stump of 0.7 cm including the distal sfa stenting.Refilling of the femoropopliteal junction directly at the distal stent end.There is strong-caliber triple-vessel outflow at the lower leg, but with an occlusion at the junction between the distal posterior tibial artery and the plantar artery.For the same, fibrinolysis was performed with initial fractionated infiltration of the entire occlusion with a total of 4 mg of actilyse of the right sfa.Subject had uncomplicated procedure and advised to continuation of local lysis according to plan and duplex angiography on the next day.On (b)(6), 2022, angiography performed revealed right superficial femoral artery was recanalized 22 hours after starting lysis, however several severe stenosis in the proximal segment, mild stenosis in the middle segment, and severe in-stent stenosis are observed also there are moderate and severe stenosis at the distal end of the stent at the femoropopliteal junction.On dsa performed with a bent knee, the stent in the distal superficial femoral artery (sfa) and popliteal artery were freely perfused without loop formation.On (b)(6), 2022, the target lesion with 90% stenosis was treated by performing in the proximal right sfa and in distal sfa using 6 mm x 80 mm balloon.Despite of prolonged balloon pta of the proximal sfa and the site of the proximal occlusion at the start of lysis, there are moderate and high-grade residual stenosis noted, hence a 7 mm x 40 mm self-expanding non-boston scientific stent was implanted.Finally, post dilatation was performed using a 6 mm x 40 mm balloon.Post intervention angiography revealed rapid inflow into the lower leg arteries and pedal arteries.No new thromboembolic event was seen.Angio morphology showed uncomplicated surgery with good outcome.On (b)(6), 2022, the event was considered to be resolved.On (b)(6), 2022, the subject was discharged with the recommendation of aspirin 100 mg as a permanent therapy and clopidogrel 75 mg for six weeks.It was further reported that the target lesion was in the right proximal superficial femoral artery.

Manufacturer Narrative

A2: age at time of event: 61 years old at time of enrollment.

Event Description

Eminent study: it was reported that stent thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2019.Target lesion was located in right mid superficial femoral artery (sfa) with 100% stenosis and was 79 mm long with a proximal reference vessel diameter of 4.76 mm and distal reference vessel diameter of 4.82 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilatation, followed by placement of a 6 mm x 100 mm eluvia drug-eluting vascular stent system.Following post dilation, residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1078 days post index procedure, the subject presented to the protocol scheduled 36 month follow up visit and duplex ultrasound was performed which revealed in-stent re-occlusion of sfa in the right limb.On (b)(6) 2022, as a part of follow up, the subject re-visited with symptoms of slight pain in the right limb and severe difficulty in walking.No action was taken to treat the event; however, revascularization has been planned to perform on a later date.It was further reported that on (b)(6) 2022, the subject presented due to pain in right leg.On the same day, duplex ultrasound was performed which revealed extensive occlusion of the right superficial femoral artery (sfa) over the entire thigh.There is a short section of residually perfused vascular stump with an attack curve at the origin of the sfa.The indwelling stent in the middle and distal thirds of the sfa is completely occluded.Pathological monophasic refill curve in the popliteal artery with significantly reduced flow rates of up to 22 cm/s.The subject was diagnosed with in-stent re-occlusion of sfa in the right limb.On (b)(5) 2022, the subject was hospitalized due to stage iib paod on the right for planned lysis of the sfa on the right.On the same day, initial angiography performed revealed in line with the ultrasound, a long section of occlusion of almost the entire sfa on the right is observed after a residual stump of 0.7 cm including the distal sfa stenting.Refilling of the femoropopliteal junction directly at the distal stent end.There is strong-caliber triple-vessel outflow at the lower leg, but with an occlusion at the junction between the distal posterior tibial artery and the plantar artery.For the same, fibrinolysis was performed with initial fractionated infiltration of the entire occlusion with a total of 4 mg of actilyse of the right sfa.Subject had uncomplicated procedure and advised to continuation of local lysis according to plan and duplex angiography on the next day.On (b)(6) 2022, angiography performed revealed right superficial femoral artery was recanalized 22 hours after starting lysis, however several severe stenosis in the proximal segment, mild stenosis in the middle segment, and severe in-stent stenosis are observed also there are moderate and severe stenosis at the distal end of the stent at the femoropopliteal junction.On dsa performed with a bent knee, the stent in the distal superficial femoral artery (sfa) and popliteal artery were freely perfused without loop formation.On (b)(6) 2022, the target lesion with 90% stenosis was treated by performing in the proximal right sfa and in distal sfa using 6 mm x 80 mm balloon.Despite of prolonged balloon pta of the proximal sfa and the site of the proximal occlusion at the start of lysis, there are moderate and high-grade residual stenosis noted, hence a 7 mm x 40 mm self-expanding non-boston scientific stent was implanted.Finally, post dilatation was performed using a 6 mm x 40 mm balloon.Post intervention angiography revealed rapid inflow into the lower leg arteries and pedal arteries.No new thromboembolic event was seen.Angio morphology showed uncomplicated surgery with good outcome.On (b)(6) 2022, the event was considered to be resolved.On (b)(6) 2022, the subject was discharged with the recommendation of aspirin 100 mg as a permanent therapy and clopidogrel 75 mg for six weeks.It was further reported that the target lesion was in the right proximal superficial femoral artery.It was further reported that on (b)(6) 2022, additional angiography assessed by core lab revealed right proximal to distal superficial femoral artery (sfa) with patent inflow and patent outflow, occlusion in-stent restenosis stenosis pattern with presence of thrombus and absence of aneurysm.On (b)(6) 2022, 1133 days post index procedure, the target lesion with 90% stenosis was treated by performing in the proximal and distal right superficial femoral artery using 6 mmx80 mm balloon.Despite of prolonged balloon percutaneous angioplasty of the proximal sfa and the site of the proximal occlusion at the start of lysis, there are moderate and high-grade residual stenoses noted, hence a 7mm x 40 mm self-expanding non-boston scientific stent was implanted and finally post dilatation was performed using a 6 mm x 40 mm balloon.Post intervention angiography revealed rapid inflow into the lower leg arteries and pedal arteries.No new thromboembolic event was seen.Angio morphology showed uncomplicated surgery with good outcome.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13970583
• MDR Text Key: 288363384
• Report Number: 2134265-2022-03445
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021863988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male
• Patient Race: White