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 Reocclusion (1985)

Event Date 09/11/2018

Event Type  Injury  

Event Description

The patient was enrolled in the eminent clinical study with the patient identifier of (b)(6).It was reported that in-stent restenosis (isr) occurred.On (b)(6) 2018, the index procedure was performed.The target lesion was located in the left mid superficial femoral artery (sfa).The target lesion had a 4.9mm proximal and a 4.7mm distal reference diameter, and was crossed through the true lumen.The lesion had 80mm of length and was 100% stenosed.Pre-dilation was performed with a 3mm balloon.A 6x100mm eluvia stent was then placed.Post-dilatation was performed using a 5mm balloon.Residual stenosis was 0% and no thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2018, the patient was diagnosed with isr in the target lesion.No further action was taken.The event is currently assessed as ongoing.

Event Description

The patient was enrolled in the eminent clinical study with the patient identifier of (b)(6).It was reported that in-stent restenosis (isr) occurred.On (b)(6) 2018, the index procedure was performed.The target lesion was located in the left mid superficial femoral artery (sfa).The target lesion had a 4.9mm proximal and a 4.7mm distal reference diameter, and was crossed through the true lumen.The lesion had 80mm of length and was 100% stenosed.Pre-dilation was performed with a 3mm balloon.A 6x100mm eluvia stent was then placed.Post-dilatation was performed using a 5mm balloon.Residual stenosis was 0% and no thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2018, the patient was diagnosed with isr in the target lesion.No further action was taken.The event is currently assessed as ongoing.It was further reported that 80% in stent restenosis was found on (b)(6) 2018.Currently no additional intervention or treatment has been performed, as the patient did not present with significant symptoms.The patient will be evaluated at the 12 month follow up on (b)(6) 2019.

• 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: 7952912
• MDR Text Key: 123275157
• Report Number: 2134265-2018-61525
• 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: 01/28/2019

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: 01/31/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019631129
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR