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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number 24653
Device Problem Fracture (1260)
Patient Problems Ischemia (1942); Reocclusion (1985); Claudication (2550)
Event Date 02/06/2020
Event Type  Injury  
Manufacturer Narrative
Patient identifier: (b)(6).
 
Event Description
(b)(6) clinical study.It was reported that the stent fractured and in-stent stenosis occurred.The subject underwent treatment with a study device on (b)(6) 2018 as part of the (b)(6) clinical trial.The target lesion was located in left distal superficial femoral artery (sfa) with 99% stenosis.The lesion was 50 mm long with a proximal reference vessel of 4.9 mm and a distal reference vessel diameter of 5.11 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of the 6 mm x 60 mm stent.Following post dilation, the residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, the subject presented with symptoms of left leg claudication.Diagnostics revealed sub-occlusive intrastent stenosis with stent degeneration and approximately 1 cm detachment of the proximal and distal segment.On (b)(6) 2020, percutaneous transluminal angioplasty (pta) was performed with a 5 mm x 80 mm drug eluting balloon.On (b)(6) 2020, follow up diagnostics revealed improvement.
 
Manufacturer Narrative
A1: patient identifier-(b)(6).
 
Event Description
Eminent clinical study.It was reported that the stent fractured and in-stent stenosis occurred.The subject underwent treatment with a study device on (b)(6) 2018 as part of the eminent clinical trial.The target lesion was located in left distal superficial femoral artery (sfa) with 99% stenosis.The lesion was 50 mm long with a proximal reference vessel of 4.9 mm and a distal reference vessel diameter of 5.11 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of the 6 mm x 60 mm stent.Following post dilation, the residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, the subject presented with symptoms of left leg claudication.Diagnostics revealed sub-occlusive intrastent stenosis with stent degeneration and approximately 1 cm detachment of the proximal and distal segment.On (b)(6) 2020, percutaneous transluminal angioplasty (pta) was performed with a 5 mm x 80 mm drug eluting balloon.On (b)(6) 2020, follow up diagnostics revealed improvement.It was further reported that the subject presented with symptoms of left leg claudication on (b)(6) 2020.On (b)(6) 2020, the event was consider resolved.
 
Manufacturer Narrative
A1: patient identifier-(b)(6).
 
Event Description
Eminent clinical study it was reported that the stent fractured and in-stent stenosis occurred.The subject underwent treatment with a study device on (b)(6) 2018 as part of the eminent clinical trial.The target lesion was located in left distal superficial femoral artery (sfa) with 99% stenosis.The lesion was 50 mm long with a proximal reference vessel of 4.9 mm and a distal reference vessel diameter of 5.11 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of the 6 mm x 60 mm stent.Following post dilation, the residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6), 2020, the subject presented with symptoms of left leg claudication.Diagnostics revealed sub-occlusive intrastent stenosis with stent degeneration and approximately 1 cm detachment of the proximal and distal segment.On (b)(6) 2020, percutaneous transluminal angioplasty (pta) was performed with a 5 mm x 80 mm drug eluting balloon.On (b)(6) 2020, follow up diagnostics revealed improvement.It was further reported that the subject presented with symptoms of left leg claudication on (b)(6) 2020.On (b)(6) 2020, the event was consider resolved.It was further reported that the subject presented with symptoms of left leg claudication on (b)(6) 2020 which had an onset date of(b)(6) 2020.
 
Manufacturer Narrative
A1: patient identifier (b)(6).
 
Event Description
Eminent clinical study it was reported that the stent fractured and in-stent stenosis occurred.The subject underwent treatment with a study device on (b)(6)2018 as part of the eminent clinical trial.The target lesion was located in left distal superficial femoral artery (sfa) with 99% stenosis.The lesion was 50 mm long with a proximal reference vessel of 4.9 mm and a distal reference vessel diameter of 5.11 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of the 6 mm x 60 mm stent.Following post dilation, the residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6), 2020, the subject presented with symptoms of left leg claudication.Diagnostics revealed sub-occlusive intrastent stenosis with stent degeneration and approximately 1 cm detachment of the proximal and distal segment.On (b)(6), 2020, percutaneous transluminal angioplasty (pta) was performed with a 5 mm x 80 mm drug eluting balloon.On (b)(6)2020, follow up diagnostics revealed improvement.It was further reported that the subject presented with symptoms of left leg claudication on (b)(6) 2020.On (b)(6) 2020, the event was consider resolved.It was further reported that the subject presented with symptoms of left leg claudication on (b)(6) 2020 which had an onset date of (b)(6)2020.It was further reported that the subject presented with symptoms of left leg pain and claudication, after walking for a short distance of less than 100 m, along with feeling of cold at the time of resting, without any pain on (b)(6) 2020.These symptoms were reported to be persisting since the previous month.On (b)(6)2020, the subject visited as an outpatient and on examination, the pathological state of the left leg pulses was higher than the right.On the same day, an arterial ultrasound scan revealed 80-90% intra-stent stenosis at the adductor canal/ femoropopliteal transition.The subject was diagnosed with pre-critical ischemia of the left leg along with severe stenosis of the femoropopliteal transition and an intervention for the same was planned on a later day.On (b)(6), 2020, the subject visited as an outpatient for planned pta to treat intrastent stenosis of the left superficial femoral artery.90% stenosis in the left distal sfa (target lesion), which was 85 mm lesion length and diameter of 5 mm was treated with angioplasty using 5 mm x 80 mm drug eluting balloon with 20% residual stenosis.Post procedurally, a good angiographic result was confirmed.The left leg pulses and plethysmographic curves along with pressure values had a significant improvement.On the same day, additional core lab angiography confirmed revascularization done at the target lesion (left distal sfa), successfully and there was no thrombus or aneurysm.During the event, the subject was on clopidogrel, however clopidogrel was discontinued and aspirin along with xarelto was started.
 
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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 Key9921337
MDR Text Key187888135
Report Number2134265-2020-04323
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 08/03/2020
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? Yes
Device Operator Health Professional
Device Expiration Date08/22/2018
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0020396886
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/24/2020
Initial Date FDA Received04/03/2020
Supplement Dates Manufacturer Received05/12/2020
05/27/2020
07/22/2020
Supplement Dates FDA Received05/21/2020
06/04/2020
08/03/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
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