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

Model Number 24657

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reocclusion (1985)

Event Date 10/30/2019

Event Type  Injury  

Event Description

It was reported that stent occlusion occurred.The subject was enrolled into (b)(6) study on (b)(6) 2017 and the index procedure was performed on the same day.The target lesion was located in the right superficial femoral artery (sfa) had 90% stenosis, reference vessel diameter of 4 mm, a length of 22 mm, and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation using a 4 mm x 40 mm sterling balloon otw (bsc device) followed by a 5 mm x 60 mm study balloon.Post dilatation was not performed.Residual stenosis was 10%.The subject was discharged as an outpatient on clopidogrel.On (b)(6) 2019 recurrent claudication in right sfa (target lesion) was treated with pre-dilatation using 5 x 80mm stellarex balloon followed by placement of 6 x 120 x130 cm eluvia des stent.On (b)(6) 2019, during the follow-up visit, subject underwent duplex examination which revealed total occlusion from right proximal sfa to distal sfa.On (b)(6) 2019, the right sfa was treated with eluvia des stent 6 x 120 x 130 cm stent with good results and reduction in stenosis from 100% to 0%.The subject was discharged on the same day.

Event Description

It was reported that stent occlusion occurred.The subject was enrolled into ranger ii sfa study on (b)(6) 2017 and the index procedure was performed on the same day.The target lesion was located in the right superficial femoral artery (sfa) had 90% stenosis, reference vessel diameter of 4 mm, a length of 22 mm, and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation using a 4 mm x 40 mm sterling balloon otw (bsc device) followed by a 5 mm x 60 mm study balloon.Post dilatation was not performed.Residual stenosis was 10%.The subject was discharged as an outpatient on clopidogrel.On (b)(6) 2019, recurrent claudication in right sfa (target lesion) was treated with pre-dilatation using 5 x 80mm stellarex balloon followed by placement of 6 x 120 x130 cm eluvia des stent.On (b)(6) 2019, during the follow-up visit, subject underwent duplex examination which revealed total occlusion from right proximal sfa to distal sfa.On (b)(6) 2019, the right sfa was treated with eluvia des stent 6 x 120 x 130 cm stent with good results and reduction in stenosis from 100% to 0%.The subject was discharged on the same day.It was further reported that n physical examination, edema was noted in the lower extremity with 1+ and diminished pulse on the right on (b)(6) 2019.On (b)(6) 2019, the total occlusion of the right sfa was initially treated with 2.0mm turbo power laser atherectomy and percutaneous transluminal angioplasty was performed using two 6 x 200 x 150 cm armada balloons.Two 6 x 120 x 130 cm eluvia des self expanding stents were implanted.Post treatment with eluvia des, two 6 x 200 x 150 cm armada balloons were re-inflated once again.Post treatment, angiography examination revealed good results with reduction of stenosis from 100% to 0%.No complications were noted during the procedure.The patient was hemodynamically stable.On the same day, the event was considered recovered/resolved and the patient was discharged on aspirin and plavix.

• 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: 9340746
• MDR Text Key: 166980840
• Report Number: 2134265-2019-13997
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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 Model Number: 24657
• Device Catalogue Number: 24657
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR