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 Reocclusion (1985); Claudication (2550)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier - (b)(6).Date of birth: unknown (b)(6).Device is a combination product.

Event Description

(b)(6) clinical trial.It was reported that in-stent restenosis occurred.The patient underwent treatment with the study stent on (b)(6) 2017 as part of the (b)(6) clinical trial.The target lesion, located in the proximal and distal superficial femoral artery (sfa) of the left leg, had a 5.5mm and 5.5mm reference vessel diameter, proximally and distally respectively, and a total length of 30mm visually estimated.The target lesion was 90% occluded and was crossed through the true lumen.Pre-dilatation was not performed and one 6x40mm study stent was implanted.Post- dilatation was performed using one balloon, resulting in 0% residual stenosis.No thrombus was seen at the end of the procedure.On (b)(6) 2019, clinical symptomatic degradation due to proximal and distal superficial femoral artery intrastent restenosis occurred.This was resolved with sequelea on (b)(6) 2019.On (b)(6) 2019 the patient was admitted to the hospital and an intra stent revascularization was performed on (b)(6) 2019 due to the intra stent restenosis of the left sfa.The event is reported as resolved as of (b)(6) 2019.The patient was discharged from the hospital on (b)(6) 2019.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: date of birth: unknown 1950.Device is a combination product.

Event Description

Eminent clinical trial.It was reported that in-stent restenosis occurred.The patient underwent treatment with the study stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the proximal and distal superficial femoral artery (sfa) of the left leg, had a 5.5mm and 5.5mm reference vessel diameter, proximally and distally respectively, and a total length of 30mm visually estimated.The target lesion was 90% occluded and was crossed through the true lumen.Pre-dilatation was not performed and one 6x40mm study stent was implanted.Post- dilatation was performed using one balloon, resulting in 0% residual stenosis.No thrombus was seen at the end of the procedure.On (b)(6) 2019, clinical symptomatic degradation due to proximal and distal superficial femoral artery intrastent restenosis occurred.This was resolved with sequelea on (b)(6) 2019.On (b)(6) 2019, the patient was admitted to the hospital and an intra stent revascularization was performed on (b)(6) 2019 due to the intra stent restenosis of the left sfa.The event is reported as resolved as of on (b)(6) 2019.The patient was discharged from the hospital on (b)(6) 2019.It was further reported that an angioscan was performed on (b)(6) 2019, that revealed stenosis in the distal sfa and popliteal artery.Endovascular therapy was planned for both the lesions.On (b)(6) 2019, the patient noted bilateral claudication and a progressive reduction in walking distance with an estimated distance of 100m to 300m on a flat surface and decreased on steep surface and on the same day subject was admitted to site for further evaluation and treatment.Doppler ultrasound revealed, intra-stent stenosis in deep femoral artery, proximal sfa (non-target lesion) and intrastent restenosis in distal sfa (target lesion).On (b)(6) 2019, target lesion was treated with percutaneous intervention (drug eluting balloon).Following procedure, residual stenosis was at 0%.No complications were noted on puncture site and the patient eventually re-gained walking ability.Additional to previous medication regimen, the patient was recommended to take plavix for a period of 3 months.The event was considered to be recovered/resolved.On (b)(6) 2019, the patient was discharged from the hospital.

Manufacturer Narrative

A1: patient identifier - (b)(6).A2: date of birth: (b)(6) 1950.

Event Description

Eminent clinical trial: it was reported that in-stent restenosis occurred.The patient underwent treatment with the study stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the proximal and distal superficial femoral artery (sfa) of the left leg, had a 5.5mm and 5.5mm reference vessel diameter, proximally and distally respectively, and a total length of 30mm visually estimated.The target lesion was 90% occluded and was crossed through the true lumen.Pre-dilatation was not performed and one 6x40mm study stent was implanted.Post- dilatation was performed using one balloon, resulting in 0% residual stenosis.No thrombus was seen at the end of the procedure.On (b)(6) 2019, clinical symptomatic degradation due to proximal and distal superficial femoral artery intrastent restenosis occurred.This was resolved with sequelea on (b)(6) 2019.On (b)(6) 2019 the patient was admitted to the hospital and an intra stent revascularization was performed on (b)(6) 2019 due to the intra stent restenosis of the left sfa.The event is reported as resolved as of (b)(6) 2019.The patient was discharged from the hospital on (b)(6) 2019.It was further reported that an angioscan was performed on (b)(6) 2019, that revealed stenosis in the distal sfa and popliteal artery.Endovascular therapy was planned for both the lesions.On (b)(6) 2019, the patient noted bilateral claudication and a progressive reduction in walking distance with an estimated distance of 100m to 300m on a flat surface and decreased on steep surface and on the same day subject was admitted to site for further evaluation and treatment.Doppler ultrasound revealed, intra-stent stenosis in deep femoral artery, proximal sfa (non-target lesion) and intrastent restenosis in distal sfa (target lesion).On (b)(6) 2019, target lesion was treated with percutaneous intervention (drug eluting balloon).Following procedure, residual stenosis was at 0%.No complications were noted on puncture site and the patient eventually re-gained walking ability.Additional to previous medication regimen, the patient was recommended to take plavix for a period of 3 months.The event was considered to be recovered/resolved.On (b)(6) 2019, the patient was discharged from the hospital.It was further reported that on (b)(6) 2019, the subject presented to the treating site with symptoms of intermittent claudication on lower limbs.The subject was able to walk for a distance of 100 to 300 meters on flat surfaces and much less on steep ground.Doppler ultrasound was performed on both the limbs, which revealed lesions mainly on the left lower limb.On (b)(6) 2019, subject visited site for the management and underwent computed tomography (ct) angiography, which revealed intra-stent lesions on the left but also lesions at the distal portion of the sfa and the popliteal artery.These two lesions were accessible for endovascular treatment.On (b)(6) 2019, the subject was admitted to treating site for further evaluation and treatment.Doppler ultrasound revealed intrastent restenosis in the deep femoral artery and proximal superficial femoral artery, as well as intrastent restenosis in the distal sfa stent.These stenoses were estimated between 45 and 65%.Endovascular procedure to treat the event was planned on a later date.

• 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: 9285228
• MDR Text Key: 165326372
• Report Number: 2134265-2019-13419
• 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,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019735467
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR