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 Problem Thrombosis (2100)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

Age at time of event: (b)(6) years old at time of enrollment.Initial reporter address 1: (b)(6).

Event Description

It was reported that stent thrombosis occurred requiring thromboaspiration to treat.The subject was enrolled in the (b)(6) study on (b)(6) 2017 and the index procedure was performed on the same day.Target lesion was located in the right proximal and mid superficial femoral artery (sfa) with 100% stenosis.Target lesion was 140 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as a tasc ii c lesion.Target lesion was treated with pre-dilation followed by placement of a 7 mm x 150 mm study stent.Post procedure revealed 0% residual stenosis.Post procedure was not performed.On (b)(6) 2017, the subject was discharged with antiplatelet therapy.On (b)(6) 2019, the subject was diagnosed with stent thrombosis.Subject was hospitalized for further evaluation and treatment.Thromboaspiration was performed as a treatment for the event.On (b)(6) 2019, the event was considered resolved.

Event Description

It was reported that stent thrombosis occurred requiring thromboaspiration to treat.The subject was enrolled in the eminent study on (b)(6) 2017 and the index procedure was performed on the same day.Target lesion was located in the right proximal and mid superficial femoral artery (sfa) with 100% stenosis.Target lesion was 140 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as a tasc ii c lesion.Target lesion was treated with pre-dilation followed by placement of a 7 mm x 150 mm study stent.Post procedure revealed 0% residual stenosis.Post procedure was not performed.On (b)(6) 2017, the subject was discharged with antiplatelet therapy.On (b)(6) 2019, the subject was diagnosed with stent thrombosis.Subject was hospitalized for further evaluation and treatment.Thromboaspiration was performed as a treatment for the event.On (b)(6) 2019, the event was considered resolved.It was further reported that on (b)(6) 2019, the subject presented to the enrolling site with symptoms of typical intermittent claudication, which appeared in the right calf when walking 100 to 200 meters.Doppler ultrasound on the right posterior tibial artery was 60mmhg.Color duplex ultrasound scan performed on the same day revealed re-occlusion of the stent in the sfa over the entire length.No action was taken at the time of diagnosis.Subject was recommended for a re-intervention, which was planned on a later date.On (b)(6) 2019, the subject was hospitalized for planned intervention.The stent in the target lesion was fully occluded, refilling the stent end via collateral vessels from the profunda circulation.On the same day, a 6f non-boston scientific atherectomy catheter was inserted into the stent occlusion.A thrombus material was obtained in-stent for 15-min through aspiration.Follow-up images revealed a distinct residual stenosis.Hence, a 5 mm x 300 mm non-boston scientific balloon was inflated from the femoral bifurcation to the distal end of the stent.Later, a 5mm x 200mm non-boston scientific drug-eluting balloon (deb) and a 5 mm x 120 mm non-boston scientific deb were inflated with a slight overlap of the previously treated segment.Follow-up images revealed optimal revascularization.The thrombocyte aggregation inhibiting treatment with acetylsalicylic acid (asa) 100mg/day was doubled by the means of 600 mg clopidogrel.Additionally, 0.6 clexane for next 24 hours and 2 x 2.5 mg of rivaroxaban was also prescribed.Post the intense medication regimen, clopidogrel 75mg/day, asa 100mg/day, and 2 x 2.5mg rivaroxaban was prescribed for 12-months.Doppler ultrasound scan on (b)(6) 2019 in the right posterior tibial artery was at 140mmhg.On (b)(6) 2019, the subject was discharged.

Manufacturer Narrative

A2: age at time of event: 76 years old at time of enrollment.E1 initial reporter address 1: (b)(6).

• 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: 10896434
• MDR Text Key: 218226490
• Report Number: 2134265-2020-16337
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020468921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention