MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 26920

Device Problem Fracture (1260)

Patient Problems Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 08/24/2022

Event Type  Injury  

Event Description

Eminent clinical study.It was reported that the stent fractured and there was restenosis.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in right mid to distal superficial femoral artery (sfa) involving proximal popliteal artery with 90% stenosis and was 210 mm long with a proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 6.0 mm and was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation, followed by placement of 6 mm x 150 mm and 6 mm x 80 mm study stents.Following post dilation, residual stenosis was 10%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1380 days post index procedure, the subject was presented with recurring claudication in both calves, on the right more than on the left and no pain at rest or wounds.On the same day arterial duplex of lower extremities performed did not show a clear focal stenosis on the right, low flow in the entire sfa with weak flow in the pta and peroneal artery and lower flow in the iliac axis as well.On arrival rutherford category was 2.On (b)(6) 2022, 1380 days post index procedure subject was diagnosed with restenosis right leg.On (b)(6) 2022, the subject was hospitalized for further treatment and evaluation.Upon consultation, the subject was recommended to undergo surgical intervention as a treatment for the event.On (b)(6) 2022, 1389 days post index procedure, 75% stenosis in the right mid to distal sfa including proximal popliteal artery (target lesion) with 210 mm lesion length and reference vessel diameter of 6 mm was treated by performing percutaneous transluminal angioplasty using 5 mm x 150 mm admiral balloon, followed by pta of popliteal artery was performed using 4 mm x 40 mm and 5 mm x 150 mm admiral balloon.Post procedure, resulted in no complications and 5% of residual stenosis with absence of thrombus.Angio performed after the procedure, revealed 50 % stenosis at proximal sfa stent.On (b)(6) 2022, 1389 days post index procedure, 90% stenosis in the right proximal sfa (non-target lesion) with 90 mm lesion length and reference vessel diameter of 6 mm was treated by performing percutaneous transluminal angioplasty using 5 mm x 150 mm admiral balloon and then implantation of 6 mm x 100 mm eluvia stent was done.Post procedure, resulted in 5% of residual stenosis with absence of thrombus and no signs of bleeding and pseudo-aneurysms.Angio showed 20% of stenosis at the p2 segment.Post operative abi at right revealed dorsalis pedis artery is 115 and posterior tibial artery is 120.On (b)(6) 2022, 1389 days post index procedure, sfa and popliteal distal part stent fracture was noticed during revascularization procedure.No action was taken for the fractured stent.The subject was discharged with the recommendation of dafalgan 1 g, asaflow 80 mg and clopidogrel 75 mg for three months and later, asaflow can be continued alone.The outcome was ongoing.

Event Description

Eminent clinical study.It was reported that the stent fractured and there was restenosis.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in right mid to distal superficial femoral artery (sfa) involving proximal popliteal artery with 90% stenosis and was 210 mm long with a proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 6.0 mm and was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation, followed by placement of 6 mm x 150 mm and 6 mm x 80 mm study stents.Following post dilation, residual stenosis was 10%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1380 days post index procedure, the subject was presented with recurring claudication in both calves, on the right more than on the left and no pain at rest or wounds.On the same day arterial duplex of lower extremities performed did not show a clear focal stenosis on the right, low flow in the entire sfa with weak flow in the pta and peroneal artery and lower flow in the iliac axis as well.On arrival rutherford category was 2.On (b)(6) 2022, 1380 days post index procedure subject was diagnosed with restenosis right leg.On (b)(6) 2022, the subject was hospitalized for further treatment and evaluation.Upon consultation, the subject was recommended to undergo surgical intervention as a treatment for the event.On (b)(6) 2022, 1389 days post index procedure, 75% stenosis in the right mid to distal sfa including proximal popliteal artery (target lesion) with 210 mm lesion length and reference vessel diameter of 6 mm was treated by performing percutaneous transluminal angioplasty using 5 mm x 150 mm admiral balloon, followed by pta of popliteal artery was performed using 4 mm x 40 mm and 5 mm x 150 mm admiral balloon.Post procedure, resulted in no complications and 5% of residual stenosis with absence of thrombus.Angio performed after the procedure, revealed 50 % stenosis at proximal sfa stent.On (b)(6) 2022, 1389 days post index procedure, 90% stenosis in the right proximal sfa (non-target lesion) with 90 mm lesion length and reference vessel diameter of 6 mm was treated by performing percutaneous transluminal angioplasty using 5 mm x 150 mm admiral balloon and then implantation of 6 mm x 100 mm eluvia stent was done.Post procedure, resulted in 5% of residual stenosis with absence of thrombus and no signs of bleeding and pseudo-aneurysms.Angio showed 20% of stenosis at the p2 segment.Post operative abi at right revealed dorsalis pedis artery is 115 and posterior tibial artery is 120.On (b)(6) 2022, 1389 days post index procedure, sfa and popliteal distal part stent fracture was noticed during revascularization procedure.No action was taken for the fractured stent.The subject was discharged with the recommendation of dafalgan 1 g, asaflow 80 mg and clopidogrel 75 mg for three months and later, asaflow can be continued alone.The outcome was ongoing.It was further reported that on (b)(6) 2022, 1380 days post index procedure, the subject was presented to the clinic with unknown symptoms.On (b)(6) 2022, 1389 days post index procedure, the subject visited the clinic with recurring claudication in both calves, on the right more than on the left and no pain at rest or wounds.On clinical examination, showed positive for groin pulsations and pre-operative abi revealed, dorsalis pedis artery is 60 and posterior tibial artery is 82.On (b)(6) 2022, additional angiography assessed by core lab revealed right mid to distal sfa with not patent inflow and not patent outflow, isr stenosis pattern was na with the absence of thrombus and aneurysm.The core lab reported "more fractures in stent 1 present, type 1 and 3" and documented type 4 fracture.Based on the symptoms and diagnostic findings the subject was diagnosed with restenosis in the right leg.On (b)(6) 2022, the subject was discharged and the events were considered recovered/resolved.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15511904
• MDR Text Key: 300895221
• Report Number: 2124215-2022-35632
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2021
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0022557249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White