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 Pain (1994); Numbness (2415); Restenosis (4576)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

(b)(6) clinical trial.It was reported that an in-stent restenosis occurred.The subject was enrolled in the eminent clinical 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) involving the proximal popliteal artery and was 100% stenosed.The lesion was 50mm long with a proximal reference vessel diameter of 5.5mm and a distal reference vessel diameter of 5.5mm.The lesion was classified as a tasc ii a lesion.Treatment of the target lesion was performed with pre-dilatation followed by a placement of a 6mm x 60mm eluvia drug-eluting vascular stent system.After post dilatation, the residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, 614 days post index procedure, duplex ultrasound performed revealed loss of amplitude on the left side up to the popliteal artery with moderate in-stent stenosis at the proximal popliteal stent with subsequently high pulsatile monophasic amplitudes.The subject was diagnosed with an in-stent restenosis in the left popliteal artery.On (b)(6) 2021, 1023 days post index procedure, the subject presented to the clinic with chief complaints of progressive pain the left calf, depending on exertion, for about 4 - 5 weeks.The subject also complained of feeling of numbness in the toes after walking a distance of 300 - 400 meters, paresthesia in the toe region and increasing impairment in the day-to-day life.Walking test performed showed feeling of pressure at the left calf after walking a distance of 24 meters, tugging up to the thigh on the left side after walking 56 meters, and progressive pain in the left calf and slightly at the left thigh after walking 113 meters.Abi was 0.71 on the left.On the same day, photoplethysmography performed revealed missing strong acral volume pulse curves at d1 and d2 and indication of ventricular premature contraction at d3-d5.Based on the symptoms and diagnostic findings, the subject was diagnosed with an in-stent restenosis in the left leg.The subject was recommended to undergo interventional procedure at a later date.On (b)(6) 2021, 1050 days post index procedure, the subject was presented to the clinic for planned interventional procedure.Walking test revealed pressure at the left calf after walking a distance of 20 meters and progressive pain in the left calf after walking 54 meters.On (b)(6) 2021, 1051 days post index procedure, pelvic and leg angiography performed revealed unremarkable sfa and filiform in-stent stenosis only starts at the popliteal p1 segment treated in the left side with a stent followed by unremarkable popliteal artery in to the p2/p3 segments and complete trifurcation.The target lesion was located in the left distal sfa involving the popliteal artery and had a reference diameter of 5.55mm.The lesion was treated by percutaneous transluminal angioplasty using a 4mm x 40mm plain old balloon angioplasty and a 5mm x 80mm drug eluting balloon to treat beyond the borders of the stent.Post procedure, there were no complications or thrombus noted.On (b)(6) 2021, the duplex ultrasound performed revealed, patent femoropopliteal territory, wall irregularities in the distal femoral and popliteal regions.There was no evidence of relevant residual stenosis and biphasic amplitudes in the distal popliteal region in the left side.On the same day, photoplethysmography performed showed strong acral volume pulse curves with difference between the sides in favor of the left at d4/d5 on both sides.Walking test performed at 3 km/ hour + 12% revealed s1 and s2 were not achieved and ended after 150 meters due to dyspnea.Treadmill test performed showed significant improvement in walking distance.On (b)(6) 2021, the event was considered to be recovered/resolved and the subject was discharged on the same day with the advice of dual antiplatelet therapy.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13590572
• MDR Text Key: 286050924
• Report Number: 2134265-2022-01134
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022441780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Sex: Female
• Patient Race: White