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 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

It was reported that there was intent restenosis.The subject was enrolled in the (b)(4) study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in the left ostial superficial femoral artery (sfa) with 70% stenosis and was 50 mm long with a proximal reference vessel diameter of 5.40 mm and distal reference vessel diameter of 5.35 mm and was classified as tasc ii b lesion.The target lesion was predilated and a 6 mm x 60 mm study stent was implanted.Post procedure revealed 0% residual stenosis.The subject was treated on outpatient basis along with antiplatelet therapy.On (b)(6) 2020, the subject visited the enrolling site for the protocol scheduled 24-month follow-up visit.Rutherford classification on the same day was at 3 (severe claudication).Ankle brachial index (abi) in target limb was at 0.83.Duplex ultrasound scan performed on the same day revealed 70% restenosis intrastent.On (b)(6) 2020, the subject was hospitalized for planned intervention.On (b)(6) 2020, the target lesion was mid sfa with 70% stenosis and was 30 mm long with a reference vessel diameter of 5 mm, which was treated with percutaneous intervention using a drug coated balloon.Post procedure revealed 0% stenosis.On (b)(6) 2020, the event was considered to be recovered/ resolved.The subject was discharged from the hospital.

Manufacturer Narrative

A1: patient identifier: (b)(6).

Event Description

It was reported that there was instent restenosis.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 ostial superficial femoral artery (sfa) with 70% stenosis and was 50 mm long with a proximal reference vessel diameter of 5.40 mm and distal reference vessel diameter of 5.35 mm and was classified as tasc ii b lesion.The target lesion was predilated and a 6 mm x 60 mm study stent was implanted.Post procedure revealed 0% residual stenosis.The subject was treated on outpatient basis along with antiplatelet therapy.On (b)(6) 2020, the subject visited the enrolling site for the protocol scheduled 24-month follow-up visit.Rutherford classification on the same day was at 3 (severe claudication).Ankle brachial index (abi) in target limb was at 0.83.Duplex ultrasound scan performed on the same day revealed 70% restenosis intrastent.On (b)(6) 2020, the subject was hospitalized for planned intervention.On (b)(6) 2020, the target lesion was mid sfa with 70% stenosis and was 30 mm long with a reference vessel diameter of 5 mm, which was treated with percutaneous intervention using a drug coated balloon.Post procedure revealed 0% stenosis.On (b)(6) 2020, the event was considered to be recovered/ resolved.The subject was discharged from the hospital.It was further reported that the subject visited enrolling site for protocol scheduled 24-month follow-up with relapsing claudication in the left leg, with a major functional impact, that has been constantly getting worse on (b)(6) 2020.On clinical examination, the pulses on the right were palpable but not the left-side distal pulses.Duplex ultrasound scan performed on the same day revealed intrastent restenosis evaluated to be between 60 and 70%.Due to the clinical effect of this stenosis with the disappearance of pulses, and reappearance of symptoms, revascularization was planned on (b)(6) 2020.

• 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: 10810165
• MDR Text Key: 215326955
• Report Number: 2134265-2020-15545
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021887559
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 11/19/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR