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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); Restenosis (4576)
Event Date 08/06/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that in-stent stenosis occurred.The patient underwent treatment with the eluvia device on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the right distal superficial femoral artery (sfa), had a 6mm reference vessel diameter proximally and distally.The lesion had a total length of 80mm.The target lesion was 100% occluded and crossed subintimally.Pre-dilatation was performed using two balloons after which the 6x100mm eluvia stent was implanted.Post-dilatation was performed using one balloon.Residual stenosis was 0%.No thrombus was seen at the end of the procedure.On (b)(6) 2018 in-stent stenosis was observed.On (b)(6) 2018, the patient was admitted to the hospital and an angioplasty with stent placement was performed.The sfa was angioplastied above and below the stent with a 6mm balloon.An additional 6mmx4cm eluvia drug eluting stent was placed just distal to the existing study stent.The patient was discharged on the same day and the event was resolved.
 
Event Description
It was reported that in-stent stenosis occurred.The patient underwent treatment with the eluvia device on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the right distal superficial femoral artery (sfa), had a 6mm reference vessel diameter proximally and distally.The lesion had a total length of 80mm.The target lesion was 100% occluded and crossed subintimally.Pre-dilatation was performed using two balloons after which the 6x100mm eluvia stent was implanted.Post-dilatation was performed using one balloon.Residual stenosis was 0%.No thrombus was seen at the end of the procedure.On (b)(6) 2018 in-stent stenosis was observed.On (b)(6) 2018, the patient was admitted to the hospital and an angioplasty with stent placement was performed.The sfa was angioplastied above and below the stent with a 6mm balloon.An additional 6mmx4cm eluvia drug eluting stent was placed just distal to the existing study stent.The patient was discharged on the same day and the event was resolved.It was further reported that on (b)(6) 2018, the subject presented with symptoms of bilateral claudication and was hospitalized on the same day for further evaluation.On examination, moderate stenosis was noted in the right sfa above the stent and severely the stenosis was noted just distal to the stent.Additional angiography core lab analysis at right distal sfa and ppa revealed unknown inflow and non-patent outflow.In-stent restenosis pattern was edge proximal with absence of thrombus and aneurysm.Post treatment, angiogram revealed good results with 0% residual stenosis.The subject was recommended to continue with clopidogrel.
 
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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 Key8936978
MDR Text Key155788417
Report Number2134265-2019-10273
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
Report Date 06/11/2021
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 Date10/03/2018
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0020648712
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/06/2019
Initial Date FDA Received08/27/2019
Supplement Dates Manufacturer Received05/21/2021
Supplement Dates FDA Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
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