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 10/21/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Patient birth date: unk/(b)(6).

Event Description

It was reported that in-stent restenosis occurred.The subject underwent treatment with the 6x120mm eluvia stent on (b)(6) 2017 as part of the (b)(6) clinical study.The target lesion was located in the middle superficial femoral artery (sfa) of the right leg.The target lesion had a 5mm and 5mm reference vessel diameter, proximally and distally respectively, and a total length of 100mm visually estimated.The target lesion was 85% occluded and crossed through the true lumen.Pre-dilation was performed using one balloon and the eluvia study stent was implanted.Post-dilation was performed using a balloon, and 20% residual stenosis remained.No thrombus was seen at the end of the procedure.On (b)(6) 2019 in-stent stenosis was observed in the right limb.No treatment was performed up to date.The event is currently reported as ongoing.

Event Description

It was reported that in-stent restenosis occurred.The subject underwent treatment with the 6x120mm eluvia stent on (b)(6) 2017 as part of the eminent clinical study.The target lesion was located in the middle superficial femoral artery (sfa) of the right leg.The target lesion had a 5mm and 5mm reference vessel diameter, proximally and distally respectively, and a total length of 100mm visually estimated.The target lesion was 85% occluded and crossed through the true lumen.Pre-dilation was performed using one balloon and the eluvia study stent was implanted.Post-dilation was performed using a balloon, and 20% residual stenosis remained.No thrombus was seen at the end of the procedure.On (b)(6) 2019 in-stent stenosis was observed in the right limb.No treatment was performed up to date.The event is currently reported as ongoing.It was further reported that on (b)(6) 2020, 824 days post-index procedure, the 100% occlusion of the right mid to distal superficial femoral artery with 5mm reference vessel diameter and 120mm length was treated with thrombolysis.On (b)(6) 2020, 825 days post-index procedure, the right mid to distal sfa was treated with percutaneous transluminal angioplasty (pta).Final residual stenosis was 5%.On (b)(6) 2020 the was considered resolved.On (b)(6) 2020, the subject was discharged.

Manufacturer Narrative

Patient identifier: (b)(6).Patient birth date: (b)(6) 1953.

• 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: 9304943
• MDR Text Key: 166047163
• Report Number: 2134265-2019-13582
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020519929
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 66 YR