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 Occlusion (1984)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: (b)(6) at time of enrollment.(b)(6).

Event Description

(b)(6) study.It was reported that occlusion occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2017 and the index procedure was performed on the same day.The target lesion was located in right mid-superficial femoral artery (sfa) with 100% stenosis and was 70 mm long with a proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm and was classified as tasc ii b lesion.The lesion was treated with pre-dilatation followed by placement of a 6 mm x 100 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2017, the subject was discharged on antiplatelet therapy.On (b)(6) 2020 the subject developed occlusion in the right sfa.On (b)(6) 2020, subject was hospitalized for further evaluation and treatment.The subject was recommended to undergo surgical intervention as a treatment for this event.On (b)(6) 2020, the subject re-visited the site for planned intervention and the target lesion was proximal to distal sfa including proximal popliteal artery (ppa).The subject underwent femo-popliteal bypass at the p3 site.Followed by thromboendarterectomy with a non-bsc device.Post procedure, patient was discharged and this event was considered resolved.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: age at time of event: 64 years old at time of enrollment.E1: initial reporter facility name: (b)(6).

Event Description

Eminent clinical study.It was reported that occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2017 and the index procedure was performed on the same day.The target lesion was located in right mid-superficial femoral artery (sfa) with 100% stenosis and was 70 mm long with a proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm and was classified as tasc ii b lesion.The lesion was treated with pre-dilatation followed by placement of a 6 mm x 100 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2017, the subject was discharged on antiplatelet therapy.On (b)(6) 2020, the subject developed occlusion in the right sfa.On (b)(6) 2020, subject was hospitalized for further evaluation and treatment.The subject was recommended to undergo surgical intervention as a treatment for this event.On (b)(6) 2020, the subject re-visited the site for planned intervention and the target lesion was proximal to distal sfa including proximal popliteal artery (ppa).The subject underwent femo-popliteal bypass at the p3 site.Followed by thromboendarterectomy with a non-bsc device.Post procedure, patient was discharged and this event was considered resolved.It was further reported that the target lesion located in the right mid sfa was 50 mm long.On (b)(6) 2020, the subject had noted claudication symptoms with a pain free walking distance of 50 to 100m, after which calf pain would start.Therefore, a surgical treatment was planned on a later date.On (b)(6) 2020, the subject was hospitalized for the planned intervention.Ankle branchial index (abi) on the right was at 0.80 mmhg.On (b)(6) 2020, abi was at 1.07 mmhg.On (b)(6) 2020, the event was considered to be resolved / recovered.The subject was discharged on aspirin and atorvastatin.A follow-up in approximately three months was recommended.Additionally, platelet inhibition therapy for lifetime was recommended as long as there are no contraindications noted.

• 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: 10734006
• MDR Text Key: 213015207
• Report Number: 2134265-2020-14767
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019631130
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention