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

Model Number 24620

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

Patient Problems Reocclusion (1985); Pain (1994)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Event date was approximated from the reported event date of (b)(6) 2017.

Event Description

It was reported that restenosis occurred.The patient was enrolled in the (b)(6) study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the left leg proximal superficial femoral artery (sfa) and left leg distal sfa with 100% stenosis and was 190mm long with a proximal reference diameter of 6.0mm and distal vessel diameter 6.0mm and was classified as tasc ii b lesion.The lesion was treated with pre-dilatation and placement of a 6.0mm x 150mm and 6.0mm x 80mm study stent.Following post dilatation, residual stenosis was 0%.In (b)(6) 2017, the patient presented with a complaint of pain the left leg.On (b)(6) 2017, during the 12 month study specific follow-up, dus revealed 50-99% instent stenosis.The event was treated with angioplasty using drug coated balloon.On (b)(6) 2018, the event was considered recovered and resolved.

Manufacturer Narrative

Device is a combination product.Updated: event date.

Event Description

It was reported that restenosis occurred.The patient was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the left leg proximal superficial femoral artery (sfa) and left leg distal sfa with 100% stenosis and was 190mm long with a proximal reference diameter of 6.0mm and distal vessel diameter 6.0mm and was classified as tasc ii b lesion.The lesion was treated with pre-dilatation and placement of a 6.0mm x 150mm and 6.0mm x 80mm study stent.Following post dilatation, residual stenosis was 0%.In (b)(6) 2017, the patient presented with a complaint of pain the left leg.On (b)(6) 2017, during the 12 month study specific follow-up, dus revealed 50-99% instent stenosis.The event was treated with angioplasty using drug coated balloon.On (b)(6) 2018, the event was considered recovered and resolved.Additional information reported that on july 16, 2018, the patient presented with complaints of bilateral lower extremity claudication.Subsequently, bilateral lower extremity angiography was recommended for further evaluation and treatment.On the same day the patient underwent bilateral lower extremity angiography, which revealed: right leg: 30-40% stenosis in common iliac artery; patent stent (unknown manufacturer) in proximal external iliac artery; patent distal common iliac artery; patent internal iliac artery with moderate proximal stenosis; 60% stenosis common femoral artery; occluded sfa; calcified plaque in proximal profunda artery; 30-40% stenosis in above the knee popliteal artery; patent below the knee popliteal artery.Left leg: patent common iliac artery, external and internal iliac artery; 60-70% stenosis in mid common femoral artery; calcified plaque int he proximal profunda artery; patent sfa study stent proximally, occlusion in the mid segment; above the knee popliteal arteries were patent.Based on these findings, the patient was recommended for right and left endarterectomy with right and left femoral to an aka bypass.On (b)(6) 2018, the patient presented with complaint of pain in left leg.Due to impending failure of the study stent, on (b)(6) 2018, 718 days post index procedure, 90% isr noted in the left mid sfa was treated with angioplasty using drug-coated balloon with 0% residual stenosis.On (b)(6) 2018, the event was considered recovered/resolved.

• 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: 8232515
• MDR Text Key: 132559843
• Report Number: 2134265-2019-00018
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018822230
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR