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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Reocclusion (1985); Thrombosis (2100)
Event Date 05/15/2019
Event Type  Injury  
Manufacturer Narrative
Patient identifier: (b)(6).Device is combination product.
 
Event Description
(b)(6) clinical study.It was reported that in-stent stenosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2018 as part of the (b)(6) clinical trial.The target lesion, located in the left mid superficial femoral artery (sfa), had a 5mm reference vessel diameter proximal and distal, and a total length of 60mm visually estimated.The target lesion was 90% occluded and crossed through true lumen.Pre-dilatation was performed using one balloon.A 6x80mm study stent was implanted.Post-dilatation was performed using one balloon and no residual stenosis remained.On (b)(6) 2019, proximal in-stent stenosis was observed.No action has been taken to treat the event.
 
Event Description
Eminent clinical study.It was reported that in-stent stenosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2018 as part of the eminent clinical trial.The target lesion, located in the left mid superficial femoral artery (sfa), had a 5mm reference vessel diameter proximal and distal, and a total length of 60mm visually estimated.The target lesion was 90% occluded and crossed through true lumen.Pre-dilatation was performed using one balloon.A 6x80mm study stent was implanted.Post-dilatation was performed using one balloon and no residual stenosis remained.On (b)(6) 2019, proximal in-stent stenosis was observed.No action has been taken to treat the event.Additional information reported that on (b)(6) 2019, a revascularization of the target lesion was performed (angioplasty with stenting) due to stent thrombosis.The patient was admitted to the hospital on (b)(6) 2019 and discharged on (b)(6) 2019.The event was resolved.
 
Manufacturer Narrative
A1: patient identifier: (b)(6).Device is combination product.
 
Manufacturer Narrative
A1: patient identifier (b)(6).Device is combination product.
 
Event Description
Eminent clinical study.It was reported that in-stent stenosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2018 as part of the eminent clinical trial.The target lesion, located in the left mid superficial femoral artery (sfa), had a 5mm reference vessel diameter proximal and distal, and a total length of 60mm visually estimated.The target lesion was 90% occluded and crossed through true lumen.Pre-dilatation was performed using one balloon.A 6x80mm study stent was implanted.Post-dilatation was performed using one balloon and no residual stenosis remained.On (b)(6) 2019, proximal in-stent stenosis was observed.No action has been taken to treat the event.Additional information reported that on (b)(6) 2019, a revascularization of the target lesion was performed (angioplasty with stenting) due to stent thrombosis.The patient was admitted to the hospital on (b)(6) 2019 and discharged on (b)(6) 2019.The event was resolved.It was further reported that on (b)(6) 2018, the patient was discharged with antiplatelet therapy.On (b)(6) 2019, the event was considered recovered/resolved.On (b)(6) 2019, 312 days post index procedure, the patient developed critical intra-stent stenosis (describes as stent thrombosis) in the proximal region of the left leg.Doppler ultrasound revealed moderate intra stent stenosis in left proximal sfa with downstream moderate-stage stenosis.No action was taken to treat the event.
 
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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 Key8684231
MDR Text Key147500104
Report Number2134265-2019-06555
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
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/05/2019
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0021753956
Was Device Available for Evaluation? No
Date Manufacturer Received05/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age59 YR
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