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

Model Number 24620

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

Patient Problems Reocclusion (1985); Pain (1994); Claudication (2550)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination device.

Event Description

It was reported that revascularization occurred.On (b)(6) 2016, the patient was enrolled in the imperial study and the index procedure was performed on the same day.The target lesion one was located in the right mid superficial femoral artery (sfa) with 90% stenosis and was 40mm long with a proximal reference vessel diameter of 4.7mm and distal vessel diameter of 4.6mm and was classified as tasc ii b lesion.The target lesion was treated with predilatation and placement of a 6mmx40mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2019, the patient presented with claudication symptoms.Subsequently, the patient was asked to exercise for 5 minutes at 10% grade, post which a 0.46mm hg and 0.16mm hg drop in right and left lower extremity arterial pressure.The patient complained of pain in both calves after 2 minutes of exercise.An ankle-brachial index was performed which revealed in the right moderate arterial occlusive disease in the femoral popliteal segment of the right lower extremity.In the left, mild arterial occlusive disease in the femoral popliteal segment of the left lower extremity.A ct angiogram was performed for the intermittent claudication of both lower extremities that revealed on the right high grade stenosis in the external iliac artery (75%), severe stenosis with heavy calcifications in the common femoral artery, diffuse atherosclerotic irregularity in the mid and distal sfa.In the left, mild atherosclerosis in the left common femoral artery and mild to moderate stenosis in the mid sfa.On (b)(6) 2019, 85% of the stenosis noted in the study stent was treated with the 6mmx2mm balloon angioplasty with 10% residual stenosis.Additionally, stenosis noted in the right external iliac artery was treated with the 7mmx17mm balloon expandable stent.On the same day, the event was considered resolved.

Manufacturer Narrative

Device is a combination device.

Event Description

It was reported that revascularization occurred.On (b)(6) 2016, the patient was enrolled in the imperial study and the index procedure was performed on the same day.The target lesion one was located in the right mid superficial femoral artery (sfa) with 90% stenosis and was 40mm long with a proximal reference vessel diameter of 4.7mm and distal vessel diameter of 4.6mm and was classified as tasc ii b lesion.The target lesion was treated with predilatation and placement of a 6mmx40mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2019, the patient presented with claudication symptoms.Subsequently, the patient was asked to exercise for 5 minutes at 10% grade, post which a 0.46mm hg and 0.16mm hg drop in right and left lower extremity arterial pressure.The patient complained of pain in both calves after 2 minutes of exercise.An ankle-brachial index was performed which revealed in the right moderate arterial occlusive disease in the femoral popliteal segment of the right lower extremity.In the left, mild arterial occlusive disease in the femoral popliteal segment of the left lower extremity.A ct angiogram was performed for the intermittent claudication of both lower extremities that revealed on the right high grade stenosis in the external iliac artery (75%), severe stenosis with heavy calcifications in the common femoral artery, diffuse atherosclerotic irregularity in the mid and distal sfa.In the left, mild atherosclerosis in the left common femoral artery and mild to moderate stenosis in the mid sfa.On (b)(6) 2019, 85% of the stenosis noted in the study stent was treated with the 6mmx2mm balloon angioplasty with 10% residual stenosis.Additionally, stenosis noted in the right external iliac artery was treated with the 7mmx17mm balloon expandable stent.On the same day, the event was considered resolved.Additional information reported that on (b)(6) 2018, the patient visited the hospital for the study specific 24 month follow up.Dus was performed that revealed in stent stenosis of the study stent.On (b)(6) 2019, the patient presented with claudication symptoms and was asked to exercise for 5 minute at 10% grade, post which 0.46 hg and 0.16 mm hg drop was noted in right and left lower extremity arterial pressure.The patient complained of pain in both calves after 2 minutes of exercise.On the same day, ankle-brachial index (immanuel lower arterial duplex) was performed which revealed moderate arterial occlusive disease in the femoral-popliteal segment of the right lower extremity.It also revealed mild arterial occlusive disease in the femoral-popliteal segment of the left lower extremity.On (b)(6) 2019, ct angiogram was performed for the intermittent claudication of both lower extremities that revealed in the right 75% high grade stenosis in the external iliac artery, severe stenosis with heavy calcifications in the common femoral artery, diffuse atherosclerotic irregularity in the mid and distal sfa.In the left it revealed mil atherosclerosis in the left common femoral artery, mild to moderate stenosis in the mid sfa.On (b)(6) 2019, the patient visited the hospital for intervention.An aortogram was performed that revealed patent bilateral common iliac arteries, bilateral internal iliac arteries and common femoral arteries.The angiogram revealed high grade stenosis in the right external iliac artery and in stent stenosis of the study stent in the right sfa.On the same day, the stenosis of the study stent was also treated with the deployment of a 6.0mm and 40mm stent.Following post ballooning with 6mmx2cm, repeat angiogram revealed 10% residual stenosis (tvr).There was no residual stenosis noted in the right external iliac artery after treatment.On the same day, the event was considered resolved.Follow up core lab angiography findings dated (b)(6) 2019 noted the absence of thrombus as well as aneurysm.Core lab noted the presence of isr pattern 1c.

Manufacturer Narrative

Device is a combination device.

Event Description

It was reported that revascularization occurred.On (b)(6) 2016, the patient was enrolled in the imperial study and the index procedure was performed on the same day.The target lesion one was located in the right mid superficial femoral artery (sfa) with 90% stenosis and was 40mm long with a proximal reference vessel diameter of 4.7mm and distal vessel diameter of 4.6mm and was classified as tasc ii b lesion.The target lesion was treated with predilatation and placement of a 6mmx40mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2019, the patient presented with claudication symptoms.Subsequently, the patient was asked to exercise for 5 minutes at 10% grade, post which a 0.46mm hg and 0.16mm hg drop in right and left lower extremity arterial pressure.The patient complained of pain in both calves after 2 minutes of exercise.An ankle-brachial index was performed which revealed in the right moderate arterial occlusive disease in the femoral popliteal segment of the right lower extremity.In the left, mild arterial occlusive disease in the femoral popliteal segment of the left lower extremity.A ct angiogram was performed for the intermittent claudication of both lower extremities that revealed on the right high grade stenosis in the external iliac artery (75%), severe stenosis with heavy calcifications in the common femoral artery, diffuse atherosclerotic irregularity in the mid and distal sfa.In the left, mild atherosclerosis in the left common femoral artery and mild to moderate stenosis in the mid sfa.On (b)(6) 2019, 85% of the stenosis noted in the study stent was treated with the 6mmx2mm balloon angioplasty with 10% residual stenosis.Additionally, stenosis noted in the right external iliac artery was treated with the 7mmx17mm balloon expandable stent.On the same day, the event was considered resolved.Additional information reported that on (b)(6) 2018, the patient visited the hospital for the study specific 24 month follow up.Dus was performed that revealed in stent stenosis of the study stent.On (b)(6) 2019, the patient presented with claudication symptoms and was asked to exercise for 5 minute at 10% grade, post which 0.46 hg and 0.16 mm hg drop was noted in right and left lower extremity arterial pressure.The patient complained of pain in both calves after 2 minutes of exercise.On the same day, ankle-brachial index (immanuel lower arterial duplex) was performed which revealed moderate arterial occlusive disease in the femoral-popliteal segment of the right lower extremity.It also revealed mild arterial occlusive disease in the femoral-popliteal segment of the left lower extremity.On (b)(6) 2019, ct angiogram was performed for the intermittent claudication of both lower extremities that revealed in the right 75% high grade stenosis in the external iliac artery, severe stenosis with heavy calcifications in the common femoral artery, diffuse atherosclerotic irregularity in the mid and distal sfa.In the left it revealed mil atherosclerosis in the left common femoral artery, mild to moderate stenosis in the mid sfa.On (b)(6) 2019, the patient visited the hospital for intervention.An aortogram was performed that revealed patent bilateral common iliac arteries, bilateral internal iliac arteries and common femoral arteries.The angiogram revealed high grade stenosis in the right external iliac artery and in stent stenosis of the study stent in the right sfa.On the same day, the stenosis of the study stent was also treated with the deployment of a 6.0mm and 40mm stent.Following post ballooning with 6mmx2cm, repeat angiogram revealed 10% residual stenosis (tvr).There was no residual stenosis noted in the right external iliac artery after treatment.On the same day, the event was considered resolved.Follow up core lab angiography findings dated (b)(6) 2019 noted the absence of thrombus as well as aneurysm.Core lab noted the presence of isr pattern 1c.Additional information reported that on (b)(6) 2019, the velocities noted in the right sfa were: prox sfa (64 cm/s-biphasic), mid sfa (71 184 190 cm/s-biphasic); distal sfa (153 cm/s-biphasic).In the left sfa the velocities noted were: prox sfa (99 cm/s-triphasic), mid sfa (123 cm/s-triphasic), distal sfa (234 54 cm/s-triphasic).On (b)(6) 2019, the ct angiogram also revealed in the right side there was a patent common iliac artery, metastatic irregularity noted in the internal iliac vessels, short high-grade stenosis in the external iliac artery (75%), severe stenosis with heavy calcifications in the common femoral artery, diffuse atherosclerotic irregularity in the mid and distal sfa, mild irregularity in the popliteal artery, diffuse atherosclerotic irregularity in the posterior tibial and peroneal arteries and occlusion in the anterior tibial artery.The ct revealed that on the left side there was mild atherosclerosis in the left common femoral artery, mild to moderate stenosis in the mid sfa, mild atherosclerosis noted in the popliteal artery, diseased anterior tibial artery with intermittent segments of occlusion and moderate atherosclerotic irregularity in the posterior tibial and peroneal arteries.It was confirmed that there was in stent stenosis noted in the study stent implanted during the index procedure.On (b)(6) 2019, 1064 days post index procedure, in stent stenosis noted in the study stent was treated by performing balloon angioplasty with 6 mm x 2 cm balloon and the placement of stent.Following, balloon angioplasty, repeat angiogram was performed, that revealed no residual stenosis (tvr).Additionally, stenosis noted in the right external iliac artery was treated with the 7 mm x 17mm balloon expandable stent without residual stenosis.On the same day, the event was considered resolved.

• Brand Name: ELUVIATM 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: 8492814
• MDR Text Key: 141240830
• Report Number: 2134265-2019-03545
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018286213
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR