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 Obstruction/Occlusion (2422); Movement Disorder (4412); Arteriosclerosis/ Atherosclerosis (4437); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier a1: (b)(6).

Event Description

Eminent clinical study.It was reported there was in-stent occlusion/thrombosis.The subject was enrolled in the eminent study on (b)(6) 2020 and the index procedure was performed on the same day.Target lesion was located in the left mid to distal sfa with 100% stenosis and was 55 mm long with a proximal reference vessel diameter of 5.5 mm and distal reference vessel diameter of 5.0 mm and was classified as a tasc ii a lesion.Target lesion was treated with pre-dilatation, followed by 6 mm x 80 mm study stent was placed.Post dilatation was performed with final residual stenosis of 0%.On 23jan2020, the subject was discharged.On (b)(6) 2020, 177 days post index procedure, the subject presented with symptoms of intermittent claudication along with worsening mobility, hence sspb (short physical performance battery) test showed score 4 to 3, 6-minute walk test revealed 240 to 120 m, tinetti was 13 to16 as worsening of balance and gait were observed and a reduction in everyday activity over the past month was reported.Due to worsening of symptoms, leriche-fontaine was classified as class iii.On physical examination, weak pulses were observed in the lower limbs.Arterial color doppler ultrasound of the lower limbs revealed evidence of sub-occlusive stenosis in the middle tract and intrastent occlusion in the distal tract of the left superior femoral artery.Left posterior tibial artery diffusely atheromatous and calcified, closed and the middle-distal tract and well adapted to the distal tract.Left anterior tibial artery closed in the proximal tract and poorly adapted to the distal tract.Based on the findings, subject was diagnosed with stent thrombosis, and the subject was advised to discontinue tenormin and start fripass 50 mg for two weeks.On (b)(6) 2021, during the 12- month follow up visit, patency analysis on the left revealed occluded instent stenosis and stenosis category was determined by absolute psv (peak systolic velocity).At the time of reporting, the event was not recovered/ not resolved.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14987713
• MDR Text Key: 295704536
• Report Number: 2134265-2022-06991
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023393122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Race: White