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 Thrombosis (2100)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(6) clinical study.The subject was enrolled in the (b)(6) study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in right distal superficial femoral artery (sfa) involving the proximal popliteal artery (ppa) with 100% stenosis.The target lesion was 140 mm long with a proximal reference vessel diameter of 5.5 mm and distal reference vessel diameter of 5 mm and was classified as tasc ii b lesion.Treatment was performed with pre-dilatation followed by placement of 6 mm x 120 mm, 6mm x 60mm and a 6m x 40mm study stents.Another 6mm x 60mm study stent was implanted.Following post dilation, residual stenosis was 20%.On (b)(6) 2019, the subject was discharged on dual antiplatelet therapy.On (b)(6) 2020, the subject had developed thrombotic re-occlusion in the 6 mm x 120 mm stent in the target lesion.On the same day, subject was hospitalized for further evaluation and treatment.Diagnosis revealed that the target lesion was located in right distal sfa involving ppa with 100% stenosis with a reference vessel diameter of 6.0 mm, with presence of thrombus.The lesion was treated with rotation thrombectomy, followed by percutaneous transluminal angioplasty using two 6mm x 150mm ranger drug coated balloon.Post intervention revealed 0% residual stenosis without thrombus.The subject was recommended for dual platelet aggregation inhibition with acetylsalicylic acid (asa) 100mg/day as long-term therapy and 75mg of clopidogrel daily for 6 months.On (b)(6) 2020, event was considered resolved/ recovered.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: age at time of event: 70 years old at time of enrollment.E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).

Event Description

Eminent clinical study.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in right distal superficial femoral artery (sfa) involving the proximal popliteal artery (ppa) with 100% stenosis.The target lesion was 140 mm long with a proximal reference vessel diameter of 5.5 mm and distal reference vessel diameter of 5 mm and was classified as tasc ii b lesion.Treatment was performed with pre-dilatation followed by placement of 6 mm x 120 mm, 6mm x 60mm and a 6m x 40mm study stents.Another 6mm x 60mm study stent was implanted.Following post dilation, residual stenosis was 20%.On (b)(6) 2019, the subject was discharged on dual antiplatelet therapy.On (b)(6) 2020, the subject had developed thrombotic re-occlusion in the 6 mm x 120 mm stent in the target lesion.On the same day, subject was hospitalized for further evaluation and treatment.Diagnosis revealed that the target lesion was located in right distal sfa involving ppa with 100% stenosis with a reference vessel diameter of 6.0 mm, with presence of thrombus.The lesion was treated with rotation thrombectomy, followed by percutaneous transluminal angioplasty using two 6mm x 150mm ranger drug coated balloon.Post intervention revealed 0% residual stenosis without thrombus.The subject was recommended for dual platelet aggregation inhibition with acetylsalicylic acid (asa) 100mg/day as long-term therapy and 75mg of clopidogrel daily for 6 months.On (b)(6) 2020, event was considered resolved/ recovered.It was further reported that on (b)(6) 2019 only one 6mm x 60mm study stent was implanted.It was initially reported that two 6mm x 60mm study stents were implanted.

• 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: 10733702
• MDR Text Key: 213009334
• Report Number: 2134265-2020-14759
• 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: 12/09/2020

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: 09/13/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022768645
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention