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 (2100); Numbness (2415); Claudication (2550)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) clinical study.It was reported that in stent thrombosis occurred.The subject underwent treatment with a study device on (b)(6) 2017 as part of the eminent clinical trial.The target lesion was located in right mild to distal superficial femoral artery (sfa) extending to the proximal popliteal artery with 100% stenosis.The lesion was 140 mm long with a proximal reference vessel of 6 mm and a distal reference vessel diameter of 5 mm and was classified as a tasc ii c lesion.The target lesion was treated with pre-dilatation and placement of the 6 mm x 150 mm stent.Following post dilation, the residual stenosis was 5%.The subject was discharged on dual antiplatelet therapy.On (b)(6) 2017, the subject experienced significant reduction in pain free walking.Right side calf claudication and numbness in the right foot since (b)(6) 2017 which increases when prone.Duplex ultrasound was performed revealing acute stent occlusion of the stent implanted in the distal sfa.At the time of the event the subject was on aspirin.The subject was hospitalized for further management of event.Right antegrade femoral angiography revealed the proximal and mid-section of the superficial femoral artery (sfa) was stretched thin and altered by severe atherosclerosis, but open with high-grade stenosis.The stent in the distal sfa and proximal popliteal artery was completely occluded along its entire length.The occluded stent was then passed through several times with a 6f rotarex thrombectomy catheter.Post which high grade residual stenosis was noted in popliteal artery below the stent as well as at the entrance of the stent in the distal sfa.It was decided to place a 5 mm x 80 mm non-bsc nitinol stent overlapping with the 6 mm x 150 mm study stent and post dilated.On visualization, it was noted the residual thrombotic material remained at the mid-section and entrance of the study stent.Therefore, the 6f rotarex thrombectomy catheter was once again passed through the distal sfa and dilated with drug coated balloon.A good flow was noted through the arteries; no evidence of peripheral embolism and the surgery was completed without any complications.Post surgery, the subject received a loading dose of 300 mg of clopidogrel.The subject was recommended to re-start taking 75 mg of clopidogrel and continue 100 mg of aspirin.On (b)(6) 2017, the event was considered resolved.On (b)(6) 2017, color doppler sonography revealed in spite of discomfort in the right popliteal fossa and calf after 5 minutes of walking on the treadmill, the superficial femoral artery and right popliteal artery are open with strong, monophasic flow.On (b)(6) 2017, the subject was discharged to be followed-up on a later date.

Manufacturer Narrative

Patient identifier: (b)(6).Initial reporter address 1: (b)(6).

Event Description

Eminent clinical study.It was reported that in stent thrombosis occurred.The subject underwent treatment with a study device on (b)(6) 2017 as part of the eminent clinical trial.The target lesion was located in right mild to distal superficial femoral artery (sfa) extending to the proximal popliteal artery with 100% stenosis.The lesion was 140 mm long with a proximal reference vessel of 6 mm and a distal reference vessel diameter of 5 mm and was classified as a tasc ii c lesion.The target lesion was treated with pre-dilatation and placement of the 6 mm x 150 mm stent.Following post dilation, the residual stenosis was 5%.The subject was discharged on dual antiplatelet therapy.On (b)(6) 2017, the subject experienced significant reduction in pain free walking.Right side calf claudication and numbness in the right foot since on (b)(6) 2017 which increases when prone.Duplex ultrasound was performed revealing acute stent occlusion of the stent implanted in the distal sfa.At the time of the event the subject was on aspirin.The subject was hospitalized for further management of event.Right antegrade femoral angiography revealed the proximal and mid-section of the superficial femoral artery (sfa) was stretched thin and altered by severe atherosclerosis, but open with high-grade stenosis.The stent in the distal sfa and proximal popliteal artery was completely occluded along its entire length.The occluded stent was then passed through several times with a 6f rotarex thrombectomy catheter.Post which high grade residual stenosis was noted in popliteal artery below the stent as well as at the entrance of the stent in the distal sfa.It was decided to place a 5 mm x 80 mm non-bsc nitinol stent overlapping with the 6 mm x 150 mm study stent and post dilated.On visualization, it was noted the residual thrombotic material remained at the mid-section and entrance of the study stent.Therefore, the 6f rotarex thrombectomy catheter was once again passed through the distal sfa and dilated with drug coated balloon.A good flow was noted through the arteries; no evidence of peripheral embolism and the surgery was completed without any complications.Post surgery, the subject received a loading dose of 300 mg of clopidogrel.The subject was recommended to re-start taking 75 mg of clopidogrel and continue 100 mg of aspirin.On (b)(6) 2017, the event was considered resolved.On (b)(6) 2017, color doppler sonography revealed in spite of discomfort in the right popliteal fossa and calf after 5 minutes of walking on the treadmill, the superficial femoral artery and right popliteal artery are open with strong, monophasic flow.On (b)(6) 2017, the subject was discharged to be followed-up on a later date.It was further reported that the onset date for acute in-stent re-occlusion was on (b)(6) 2017.This was previously reported as on (b)(6) 2017.

• 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
• MDR Report Key: 10649689
• MDR Text Key: 210430469
• Report Number: 2134265-2020-13864
• 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
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020283003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR