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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number 24620
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Occlusion (1984); Reocclusion (1985)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: first day of the year in 2019 chosen as the event date was reported as an "unknown date in 2019.".
 
Event Description
It was reported that the patient experienced in-stent occlusion.The patient was enrolled in the imperial study and on (b)(6) 2016 the index procedure was completed.The target lesion was located in the right distal superficial femoral artery (sfa) and had 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 5.00 mm and distal vessel diameter of 5.00 mm.The lesion was classified as tasc ii a lesion.The lesion was treated with pre-dilatation and placement of a 6.0 x 150mm eluviatm drug-eluting vascular stent system.Following post-dilatation, residual stenosis was 0%.On an unknown day of 2019, the subject was noted to have an occlusion in the study stent that was implanted in the right mid sfa during the index procedure.The subject was asymptomatic.In response to the event, no action was taken.No further complications were reported.
 
Manufacturer Narrative
Patient codes: corrected from 1985 (reocclusion) to 1984 (occlusion).Date of event: first day of the year in 2019 chosen as the event date was reported as an "unknown date in 2019.".
 
Event Description
It was reported that the patient experienced in-stent occlusion.The patient was enrolled in the imperial study and on (b)(6) 2016 the index procedure was completed.The target lesion was located in the right distal superficial femoral artery (sfa) and had 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 5.00 mm and distal vessel diameter of 5.00 mm.The lesion was classified as tasc ii a lesion.The lesion was treated with pre-dilatation and placement of a 6.0 x 150mm eluviatm drug-eluting vascular stent system.Following post-dilatation, residual stenosis was 0%.On an unknown day of 2019, the subject was noted to have an occlusion in the study stent that was implanted in the right mid sfa during the index procedure.The subject was asymptomatic.In response to the event, no action was taken.No further complications were reported.It was further reported that the "unknown day" was (b)(6) 2019, which was a study specific 36 month follow up.The patient had no claudication symptoms.The patient underwent a doppler ultrasound of the bilateral lower legs which revealed: the complete occlusion of the stented sfa over a length of 20 cm; popliteal signal measures 40 cm/s which was noted to be monophasic with complete in-stent occlusion.No stent deformation or fractures were noted.Due to asymptomatic re-occlusion, the patient was recommended for walking training.
 
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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 Key8577687
MDR Text Key143962519
Report Number2134265-2019-04767
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 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2017
Device Model Number24620
Device Catalogue Number24620
Device Lot Number0018390231
Was Device Available for Evaluation? No
Date Manufacturer Received05/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age59 YR
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