MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24620

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reocclusion (1985)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that in-stent restenosis (isr) occurred.The patient was enrolled in the (b)(6) study on (b)(6) 2016, and the index procedure was performed the same day.The target lesion was located in the right proximal superficial femoral artery (sfa) extending up to the mid and distal sfa.The target lesion was 100% stenosed.The target lesion was 140mm long, with a proximal reference diameter of 6mm and a distal reference diameter of 6mm.The lesion was treated with pre-dilatation and a 6x150mm eluvia vascular stent was placed.The lesion was then post-dilated and residual stenosis was 0%.On (b)(6) 2018, the patient presented with stenosis in the right sfa and popliteal artery, and was hospitalized on the same day.On (b)(6) 2018, the distal portion of the right sfa, involving the popliteal artery, was 99% stenosed.The lesion was treated with a drug coated balloon and residual stenosis was 25%.On (b)(6) 2018, the event was considered resolved.

Event Description

It was reported that in-stent restenosis (isr) occurred.The patient was enrolled in the imperial clinical study on (b)(6) 2016, and the index procedure was performed the same day.The target lesion was located in the right proximal superficial femoral artery (sfa) extending up to the mid and distal sfa.The target lesion was 100% stenosed.The target lesion was 140mm long, with a proximal reference diameter of 6mm and a distal reference diameter of 6mm.The lesion was treated with pre-dilatation and a 6x150mm eluvia vascular stent was placed.The lesion was then post-dilated and residual stenosis was 0%.On (b)(6) 2018, the patient presented with stenosis in the right sfa and popliteal artery, and was hospitalized on the same day.On (b)(6) 2018, the distal portion of the right sfa, involving the popliteal artery, was 99% stenosed.The lesion was treated with a drug coated balloon and residual stenosis was 25%.On (b)(6) 2018, the event was considered resolved.It was further reported that on (b)(6) 2018, doppler ultra sound revealed no significant stenosis in the sfa stent but there was poor visualization due to calcification.Pop a accelerated blood flow was observed after pro-mid calcification.Severe stenosis was suspected within the calcification.The patient was hospitalized on (b)(6) 2018 for treatment of the right sfa stenosis.On (b)(6) 2018, the patient was noted with intermittent claudication, with claudication distance <200 m.Per radiological finding, lesion was diffuse > 3 cm with lesion length of 112.00 mm with vessel diameter ((proximal 5.52 mm; distal 5.01 mm).On (b)(6) 2018, 99% stenosis located in the distal portion of the right sfa involving popliteal artery was treated with drug coated balloon.On the same day, follow-up core-lab angiography finding revealed, thrombus of grade 0, absence of aneurysm and isr.On (b)(6) 2018, event was considered recovered/ resolved and subject was discharged on same day.Of note, no stent deformation or fracture was noted for the subject, however per the baseline angiography core lab dated (b)(6) 2016 the patient was noted with radial stent deformation with no stent fracture.

• Brand Name: ELUVIATM 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: 8125273
• MDR Text Key: 129065789
• Report Number: 2134265-2018-63381
• 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: 07/17/2019

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: 02/28/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 18390231
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR