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 03/06/2019

Event Type  Injury  

Event Description

It was reported that in-stent restenosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the mid superficial femoral artery (sfa) of the left leg, had a 5.5mm and 6mm reference vessel diameter proximal and distal respectively, and a total length of 60mm visually estimated.The target lesion was 100% occluded and crossed through true lumen.Pre-dilatation was performed using one balloon, afterwards a 6x80mm eluvia stent was implanted.Post-dilatation was performed using one balloon, and 0% residual stenosis remained.On (b)(6) 2019, a high graded instent-restenosis of the target lesion in the left leg was observed.The patient was hospitalized, and a target lesion revascularization was performed.The event was assessed as serious and was resolved as of (b)(6) 2019.

Manufacturer Narrative

Initially reported that the instent-restenosis was observed on (b)(6) 2019 however additional information corrected that date to (b)(6) 2019.

Event Description

It was reported that in-stent restenosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the mid superficial femoral artery (sfa) of the left leg, had a 5.5mm and 6mm reference vessel diameter proximal and distal respectively, and a total length of 60mm visually estimated.The target lesion was 100% occluded and crossed through true lumen.Pre-dilatation was performed using one balloon, afterwards a 6x80mm eluvia stent was implanted.Post-dilatation was performed using one balloon, and 0% residual stenosis remained.On (b)(6) 2019, a high graded instent-restenosis of the target lesion in the left leg was observed.The patient was hospitalized, and a target lesion revascularization was performed.The event was assessed as serious and was resolved as of (b)(6) 2019.

Event Description

It was reported that in-stent restenosis occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the mid superficial femoral artery (sfa) of the left leg, had a 5.5mm and 6mm reference vessel diameter proximal and distal respectively, and a total length of 60mm visually estimated.The target lesion was 100% occluded and crossed through true lumen.Pre-dilatation was performed using one balloon, afterwards a 6x80mm eluvia stent was implanted.Post-dilatation was performed using one balloon, and 0% residual stenosis remained.On (b)(6) 2019, a high graded instent-restenosis of the target lesion in the left leg was observed.The patient was hospitalized, and a target lesion revascularization was performed.The event was assessed as serious and was resolved as of march 20, 2019.It was further reported that on (b)(6) 2019 the patient presented for an outpatient examination due to occasional pain at rest on the left side and left sided calf muscle claudication after walking distance of 300m.On (b)(6) 2019, the patient was hospitalized for the planned percutaneous transluminal angioplasty.At this time, rutherford assessment was noted to be 3 (severe claudication) on the left side and fontaine classification was noted to be ii b.Arterial doppler and colour duplex sonography were performed.On (b)(6) 2019, peri- procedural angiography revealed the distal segment of the arteria femoralis superficialis has a stent (target lesion) with a 90% in-stent re-stenosis, arteria femoralis communis and arteria profunda femoris were stenosis free.There are no other in-stent stenosis along the further course, however there was an non contrasted 70% constriction in the p1 segment.Additional angiography core lab revealed in-stent stenosis pattern to be focal with no thrombus or aneurysm.On the same day, directional atherectomy with coated balloon angioplasty was completed of the distal segment of the arteria femoralis superficialis (in-stent) and the arteria popliteal (p1 without contrast agent) with no relevant residual stenosis.Arterial doppler and colour duplex sonography were performed.The event was considered resolved on the same day.The patient was discharged on dapt 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: 8497682
• MDR Text Key: 141429440
• Report Number: 2134265-2019-03303
• 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,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• 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: 0019589065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR