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 Problem Thrombosis (2100)

Event Date 10/27/2020

Event Type  Injury  

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) with 97% stenosis and was 48 mm long with a proximal reference vessel diameter of 5.6 mm and distal vessel diameter of 5 mm and was classified as tasc ii a lesion.The target lesion was treated with pre-dilatation and placement of a 6 x 60 mm study stent.Following post-dilatation, residual stenosis was 10 %.On (b)(6) 2016, the subject was discharged on dual anti-platelet therapy.On (b)(6) 2020, the subject presented to hospital and underwent diagnostic tests which revealed stent thrombosis in right sfa.Ballooning, drug eluting ballooning, and stenting was performed.On (b)(6) 2020, the event was considered to be resolved.

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) with 97% stenosis and was 48 mm long with a proximal reference vessel diameter of 5.6 mm and distal vessel diameter of 5 mm and was classified as tasc ii a lesion.The target lesion was treated with pre-dilatation and placement of a 6 x 60 mm study stent.Following post-dilatation, residual stenosis was 10 %.On (b)(6) 2016, the subject was discharged on dual anti-platelet therapy.On (b)(6) 2020, the subject presented to hospital and underwent diagnostic tests which revealed stent thrombosis in right sfa.Ballooning, drug eluting ballooning, and stenting was performed.On (b)(6) 2020, the event was considered to be resolved.It was further reported that on (b)(6) 2020, the subject presented to the hospital and subsequently arteriogram of the aorta and lower extremities was performed bilaterally, which revealed the following in the lower extremities.Moderate stenosis of the common iliac arteries bilaterally; patent external iliac arteries, including the stent on the left.Patent common and deep femoral arteries.There were long occlusions in the superficial femoral arteries bilaterally, including the short stent in the middle of the right superficial.On the left, the stent in the adductor canal remained patent with a little intra-stent narrowing.The popliteal arteries were thoroughly patent and there was good distal blood supply, except for an occlusion in the right posterior tibial.On (b)(6) 2020, 1503 days post index procedure, 100% stenosis of lesion length of 320mm noted in right sfa was treated by performing aspiration thrombectomy and angioplasty at multiple levels in the superficial and proximal popliteal up to 6 mm, followed by stenting with three (3) stents.Post procedure, the residual stenosis was noted to be 0%.On the same day, the stenosis noted in right common iliac artery of 6.3mm was treated by performing angioplasty after reinversion.On (b)(6) 2020, the event was considered to be resolved.

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) with 97% stenosis and was 48 mm long with a proximal reference vessel diameter of 5.6 mm and distal vessel diameter of 5 mm and was classified as tasc ii a lesion.The target lesion was treated with pre-dilatation and placement of a 6 x 60 mm study stent.Following post-dilatation, residual stenosis was 10 %.On (b)(6) 2016, the subject was discharged on dual anti-platelet therapy.On (b)(6) 2020, the subject presented to hospital and underwent diagnostic tests which revealed stent thrombosis in right sfa.Ballooning, drug eluting ballooning, and stenting was performed.On (b)(6) 2020, the event was considered to be resolved.It was further reported that on (b)(6) 2020, the subject presented to the hospital and subsequently arteriogram of the aorta and lower extremities was performed bilaterally, which revealed the following in the lower extremities.Moderate stenosis of the common iliac arteries bilaterally; patent external iliac arteries, including the stent on the left.Patent common and deep femoral arteries.There were long occlusions in the superficial femoral arteries bilaterally, including the short stent in the middle of the right superficial.On the left, the stent in the adductor canal remained patent with a little intra-stent narrowing.The popliteal arteries were thoroughly patent and there was good distal blood supply, except for an occlusion in the right posterior tibial.On (b)(6) 2020, 1503 days post index procedure, 100% stenosis of lesion length of 320mm noted in right sfa was treated by performing aspiration thrombectomy and angioplasty at multiple levels in the superficial and proximal popliteal up to 6 mm, followed by stenting with three (3) stents.Post procedure, the residual stenosis was noted to be 0%.On the same day, the stenosis noted in right common iliac artery of 6.3mm was treated by performing angioplasty after reinversion.On (b)(6) 2020, the event was considered to be resolved.It was further reported that on (b)(6) 2020, the subject was presented to the hospital with the complaint of right calf and foot claudication after walking for 2 minutes.Subsequently, the subject underwent lower limb arterial doppler ultrasound which revealed the following: in the right limb, doppler waveforms were triphasic proximally and in the deep artery, but there was moderate stenosis in the deep proximal artery with velocity at 259 cm/sec.There was stent occlusion at the superficial artery with popliteal and distal monophasic waveforms.Ankle pressure index was measured at 0.61.In the left limb, doppler waveforms were triphasic proximally and in the deep artery, and velocities were normal in the external iliac stent.There was stent occlusion at the superficial artery with popliteal and distal monophasic waveforms and an index measured at 0.61 at ankle.Follow-up core-lab angiography finding dated (b)(6) 2020, noted grade 0 thrombus, absence of aneurysm and presence of in-stent restenosis pattern 4.No stent deformation or stent fracture was noted.

• 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: 10891182
• MDR Text Key: 217932005
• Report Number: 2134265-2020-16326
• 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,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018748020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/03/2020; 12/31/2020
• Supplement Dates FDA Received: 12/14/2020; 01/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR