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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 Problem Occlusion (1984)
Event Date 10/02/2020
Event Type  Injury  
Manufacturer Narrative
Patient identifier: (b)(6).Initial reporter address: (b)(6).
 
Event Description
(b)(6) clinical study.It was reported that in-stent occlusion occurred.The subject was enrolled in the eminent clinical study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in left mid (superficial femoral artery) sfa with 100% stenosis and was 107 mm long with a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5.7 mm and was classified as tasc ii a lesion.The target lesion was treated with direct placement of 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.The patient was discharged on antiplatelet therapy.On (b)(6) 2020, 347 days post index procedure, subject visited site for protocol scheduled 12-month follow-up visit.Rutherford classification was 3 (severe claudication) and ankle brachial index (abi) ratio was 0.64.Duplex ultrasound performed on the same day revealed stent occlusion.The event was considered non-serious.On the same day, an intervention was performed using percutaneous transluminal angioplasty (pta) to treat the event.At the time of reporting, event was ongoing.
 
Manufacturer Narrative
A1: patient identifier: (b)(6).E1: initial reporter address: (b)(6).
 
Event Description
Eminent clinical study.It was reported that in-stent occlusion occurred.The subject was enrolled in the eminent clinical study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in left mid (superficial femoral artery) sfa with 100% stenosis and was 107 mm long with a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5.7 mm and was classified as tasc ii a lesion.The target lesion was treated with direct placement of 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.The patient was discharged on antiplatelet therapy.On (b)(6) 2020, 347 days post index procedure, subject visited site for protocol scheduled 12-month follow-up visit.Rutherford classification was 3 (severe claudication) and ankle brachial index (abi) ratio was 0.64.Duplex ultrasound performed on the same day revealed stent occlusion.The event was considered non-serious.On the same day, an intervention was performed using percutaneous transluminal angioplasty (pta) to treat the event.At the time of reporting, event was ongoing.It was further reported that the patient was discharged on (b)(6) 2019.
 
Manufacturer Narrative
A1: patient identifier: (b)(6).E1: initial reporter address: (b)(6).
 
Event Description
Eminent clinical study.It was reported that in-stent occlusion occurred.The subject was enrolled in the eminent clinical study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in left mid (superficial femoral artery) sfa with 100% stenosis and was 107 mm long with a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5.7 mm and was classified as tasc ii a lesion.The target lesion was treated with direct placement of 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.The patient was discharged on antiplatelet therapy.On (b)(6) 2020, 347 days post index procedure, subject visited site for protocol scheduled 12-month follow-up visit.Rutherford classification was 3 (severe claudication) and ankle brachial index (abi) ratio was 0.64.Duplex ultrasound performed on the same day revealed stent occlusion.The event was considered non-serious.On the same day, an intervention was performed using percutaneous transluminal angioplasty (pta) to treat the event.At the time of reporting, event was ongoing.It was further reported that the patient was discharged on (b)(6) 2019.It was further reported that on (b)(6) 2020, the event was considered to be resolved/ recovered.
 
Event Description
Eminent clinical study.It was reported that in-stent occlusion occurred.The subject was enrolled in the eminent clinical study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in left mid (superficial femoral artery) sfa with 100% stenosis and was 107 mm long with a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5.7 mm and was classified as tasc ii a lesion.The target lesion was treated with direct placement of 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.The patient was discharged on antiplatelet therapy.On (b)(6) 2020, 347 days post index procedure, subject visited site for protocol scheduled 12-month follow-up visit.Rutherford classification was 3 (severe claudication) and ankle brachial index (abi) ratio was 0.64.Duplex ultrasound performed on the same day revealed stent occlusion.The event was considered non-serious.On the same day, an intervention was performed using percutaneous transluminal angioplasty (pta) to treat the event.At the time of reporting, event was ongoing.It was further reported that the patient was discharged on (b)(6) 2019.It was further reported that on (b)(6) 2020, the event was considered to be resolved/ recovered.It was further reported that on (b)(6) 2020, the subject re-visited the site with the symptoms of intermittent claudication in lower limbs with occlusive in-stent stenosis.The subject was hospitalized on the same day for further evaluation and treatment.On (b)(6) 2020, the 100% stenosed target lesion was located in the mid to distal sfa and was 140mm long with a reference vessel diameter of 5.5mm.Angiography-guided pta with a 6mm x 150 mm non-boston scientific over-the-wire balloon was performed with multiple dilatations.Post procedure revealed good angiographical results with 0% residual stenosis.The procedure was completed without any complications.On (b)(6) 2020, the subject was discharged with medications.
 
Manufacturer Narrative
A1: patient identifier: (b)(6).E1: initial reporter address: (b)(6).
 
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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 Key10740842
MDR Text Key213213607
Report Number2134265-2020-14780
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 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/19/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0023598866
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age87 YR
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