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); Thrombosis (2100)

Event Date 12/12/2019

Event Type  Injury  

Event Description

It was reported that in-stent re-occlusion occurred.On (b)(6) 2019 the subject was enrolled in the (b)(6) clinical study and the index procedure was performed with three eluvia stents on the same day.The target lesion, located in the distal superficial femoral artery (sfa) and popliteal artery of the right leg, had a 5.5mm and 5mm reference vessel diameter proximal and distal and a total length of 140mm visually estimated.The target lesion was 100% occluded and crossed through true lumen.Pre-dilatation was performed using three balloons, afterwards three eluvia stents (6x120mm, 6x60mm, and 6x40mm) were implanted.Post-dilatation was performed using two balloons, and 20% residual stenosis remained.On (b)(6) 2019 in-stent re-occlusion of the right sfa was observed within the 6x120mm stent.The subject was hospitalized on the same day and an interventional procedure took place.Atherectomy and thrombolysis were performed on (b)(6) 2019.Lithoplasty and stent implantation were performed on (b)(6) 2019.The patient was discharged on (b)(6) 2019 and the event was assessed as resolved on the same day.

Event Description

It was reported that in-stent re-occlusion occurred.On (b)(6) 2019 the subject was enrolled in the eminent clinical study and the index procedure was performed with three eluvia stents on the same day.The target lesion, located in the distal superficial femoral artery (sfa) and popliteal artery of the right leg, had a 5.5mm and 5mm reference vessel diameter proximal and distal and a total length of 140mm visually estimated.The target lesion was 100% occluded and crossed through true lumen.Pre-dilatation was performed using three balloons, afterwards three eluvia stents (6x120mm, 6x60mm, and 6x40mm) were implanted.Post-dilatation was performed using two balloons, and 20% residual stenosis remained.On (b)(6) 2019 in-stent re-occlusion of the right sfa was observed within the 6x120mm stent.The subject was hospitalized on the same day and an interventional procedure took place.Atherectomy and thrombolysis were performed on (b)(6) 2019.Lithoplasty and stent implantation were performed on (b)(6) 2019.The patient was discharged on (b)(6) 2019 and the event was assessed as resolved on the same day.It was further reported that on (b)(6) 2019 that the stent located in the right distal sfa involving the popliteal artery with 100% stenosis with the presence of thrombus.The target lesion was treated with percutaneous transluminal angioplasty, thrombolysis and was also treated using rotarex.Post intervention revealed 50% residual stenosis with thrombus.Further diagnosis revealed that the stent in located in right distal sfa involving ppa with 80% stenosis with presence of thrombus.On (b)(6) 2019 the target lesion was treated with percutaneous transluminal angioplasty, stent placement and was also treated using lithoplasty.Post intervention revealed 30% residual stenosis with no thrombus seen in the treated vessel at the end of the procedure.

• 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: 9545157
• MDR Text Key: 173967205
• Report Number: 2134265-2019-16321
• 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: 11/03/2020

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: 09/13/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022768645
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR