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); Obstruction/Occlusion (2422); Paresthesia (4421); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that occlusion occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in the left proximal to distal superficial femoral artery (sfa) involving the proximal popliteal artery (ppa) with 100% stenosis.It was 210 mm long with a proximal reference vessel diameter of 6 mm and a distal reference vessel diameter of 6 mm.It was classified as a tasc ii b lesion.The target lesion was treated with pre-dilation and placement of three study stents: 7 mm x 120 mm, 7 mm x 120 mm and 7 mm x 100 mm.Following post dilation, the residual stenosis was 28%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2021, the subject visited the enrolling site for protocol scheduled 24-month follow-up visit with moderated problem in walking.On arrival, rutherford classification was 3 (severe claudication) and the ankle brachial index (abi) was 0.7.Duplex ultrasound scan revealed occlusion in sfa and pop1 of the left leg (target lesion).No action was taken to treat the event.At the time of reporting, the event was considered ongoing.

Event Description

It was reported that occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in the left proximal to distal superficial femoral artery (sfa) involving the proximal popliteal artery (apop) with 100% stenosis.It was 210 mm long with a proximal reference vessel diameter of 6 mm and a distal reference vessel diameter of 6 mm.It was classified as a tasc ii b lesion.The target lesion was treated with pre-dilation and placement of three study stents: 7 mm x 120 mm, 7 mm x 120 mm and 7 mm x 100 mm.Following post dilation, the residual stenosis was 28%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2021, the subject visited the enrolling site for protocol scheduled 24-month follow-up visit with moderated problem in walking.On arrival, rutherford classification was 3 (severe claudication) and the ankle brachial index (abi) was 0.7.Duplex ultrasound scan revealed occlusion in sfa and pop1 of the left leg (target lesion).No action was taken to treat the event.At the time of reporting, the event was considered ongoing.It was further reported that on (b)(6) 2022, the subject was diagnosed with instent restenosis of sfa and apop left leg in the target vessel.Again on (b)(6) 2022, 1186 days post-index the subject was again diagnosed with instent restenosis of sfa and apop left leg in the target vessel and hospitalized for further treatment.On (b)(6) 2022, 1187 days post index procedure, the target lesion with 90% stenosis (left proximal to distal sfa including proximal popliteal artery) with 300 mm lesion length and reference vessel diameter of 7 mm was treated by plain old balloon angioplasty (poba), followed by percutaneous transluminal angioplasty using cutting balloon and drug coated balloon.Post-procedure, there was 30% of residual stenosis with absence of thrombus.On (b)(6) 2022, the event was considered resolved.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).

Event Description

It was reported that occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in the left proximal to distal superficial femoral artery (sfa) involving the proximal popliteal artery (apop) with 100% stenosis.It was 210 mm long with a proximal reference vessel diameter of 6 mm and a distal reference vessel diameter of 6 mm.It was classified as a tasc ii b lesion.The target lesion was treated with pre-dilation and placement of three study stents: 7 mm x 120 mm, 7 mm x 120 mm and 7 mm x 100 mm.Following post dilation, the residual stenosis was 28%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2021, the subject visited the enrolling site for protocol scheduled 24-month follow-up visit with moderated problem in walking.On arrival, rutherford classification was 3 (severe claudication) and the ankle brachial index (abi) was 0.7.Duplex ultrasound scan revealed occlusion in sfa and pop1 of the left leg (target lesion).No action was taken to treat the event.At the time of reporting, the event was considered ongoing.It was further reported that on (b)(6) 2022, the subject was diagnosed with instent restenosis of sfa and apop left leg in the target vessel.Again on (b)(6) 2022, 1186 days post-index the subject was again diagnosed with instent restenosis of sfa and apop left leg in the target vessel.On (b)(6) 2022, 1187 days post index procedure, the target lesion with 90% stenosis (left proximal to distal sfa including proximal popliteal artery) with 300 mm lesion length and reference vessel diameter of 7 mm was treated by plain old balloon angioplasty (poba), followed by percutaneous transluminal angioplasty using cutting balloon and drug coated balloon.Post-procedure, there was 30% of residual stenosis with absence of thrombus.At the time of event reporting, the outcome was considered ongoing.It was further reported that on (b)(6) 2022, 1186 days post-index the subject presented with typical claudication symptoms in the region of the bilateral calves after approximately 200-300 meters of walking, considerable pain in both legs after climbing two flights of stairs, tingling/coldness feeling in both feet.Physical examination revealed inguinal pulses and further peripherally located pulses were not palpable with certainty.On arrival, rutherford classification was 3.On (b)(6) 2022, pre-interventional angiography on the left revealed internal iliac artery with high-grade stenosis from the outflow, external iliac artery with moderate grade stenosis from the outflow and deep femoral artery with high-grade stenosis over the stent, superficial femoral artery and popliteal artery stented in segment 1, multiple areas of high-grade instent restenosis were noted.The subject was diagnosed with clinical symptom stage fontaine iib with instent restenosis of sfa and popliteal artery on the left.Treatment that was initially indicated as plain old angioplasty (poba) was further reported as performed using pre-dilatation using 4 mm x 20 mm sterling balloon angioplasty (poba), then 6 mm x 20 mm cutting balloon was dilated in the stent region with subsequent 7 mm x 120 mm two ranger drug -coated balloons.Post-procedure there was good strong femoropopliteal flow including via the deep femoral artery with well-retained double-vessel lower leg perfusion through to the distal region were observed.On (b)(6) 2022, the event was considered as recovered/ resolved and the subject was discharged on the same day with recommendation to continue dual antiplatelet therapy with clopidogrel 75 mg and asa 100 mg for three months, followed by asa 100 mg daily for life.

Manufacturer Narrative

E1: initial reporter facility name: (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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11496543
• MDR Text Key: 240104621
• Report Number: 2134265-2021-03259
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022250710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Race: White