MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Thrombosis/Thrombus (4440)

Event Date 09/25/2020

Event Type  Injury  

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2018, and the index procedure was performed on the same day.The target lesion was located in the left distal superficial femoral artery (sfa) with 99% stenosis, and it was 30 mm long with a proximal reference vessel diameter of 4.38 mm and a distal reference vessel diameter of 4.11 mm.It was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation followed by placement of a 6 mm x 40 mm study stent.Post-dilation, the residual stenosis was 0%.On (b)(6) 2018, the subject was discharged on aspirin and clopidogrel on (b)(6) 2020, the subject was diagnosed with stent thrombosis.On (b)(6) 2020, the subject was hospitalized for planned intervention.On the same day, the target lesion was treated with percutaneous transluminal angioplasty (pta).On (b)(6) 2020, the subject was planned to be discharged.

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2018, and the index procedure was performed on the same day.The target lesion was located in the left distal superficial femoral artery (sfa) with 99% stenosis, and it was 30 mm long with a proximal reference vessel diameter of 4.38 mm and a distal reference vessel diameter of 4.11 mm.It was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation followed by placement of a 6 mm x 40 mm study stent.Post-dilation, the residual stenosis was 0%.On (b)(6) 2018, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject was diagnosed with stent thrombosis.On (b)(6) 2020, the subject was hospitalized for planned intervention.On the same day, the target lesion was treated with percutaneous transluminal angioplasty (pta).On (b)(6) 2020, the subject was planned to be discharged.It was further reported that on (b)(6) 2020, a duplex ultrasound scan revealed closure and occlusion of the mid to distal sfa.On (b)(6) 2020, the target lesion in the left mid to distal sfa was 100% stenosed and 100mm in length with a reference vessel diameter of 5mm.The target lesion was treated by performing thrombectomy with a non-boston scientific device, performing percutaneous transluminal angioplasty with a 5mm x 80mm balloon, and placing a 5mm x 40mm stent.Dual antiplatelet therapy with acetylsalicylic acid (asa) 100mg/day and brilique 2x 90mg/day until (b)(6) 2021 was recommended.On (b)(6) 2020, the event was resolved/recovered.

• 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 Key: 10868250
• MDR Text Key: 217115278
• Report Number: 2134265-2020-16075
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021023313
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR