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); Claudication (2550)

Event Date 09/12/2019

Event Type  Injury  

Event Description

It was reported that intermittent claudication occurred.The subject was enrolled in the imperial clinical study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the left distal superficial femoral artery (sfa) with 95% stenosis.The target lesion was 120 mm long with a proximal reference vessel diameter of 4 mm and distal vessel diameter of 4.5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilation and placement of a 6mm x 150mm eluvia study stent.Residual stenosis was 0% following post-dilation.On (b)(6) 2019, 1266 days post-index procedure, the subject had a complaint of intermittent claudication of the left lower extremity.On (b)(6) 2019, 1293 days post-index procedure, the subject was admitted to the hospital with a history of recurrent stenosis of the proximal end of previously constructed left femoropopliteal bypass.Angiogram was performed on the same day which revealed high grade stenosis at the proximal and beyond the proximal anastomosis of previously constructed femoropopliteal bypass, two vessel run-off in the foot in the form of peroneal artery and anterior tibial artery.The 100% stenosis was located in the left proximal, mid and distal sfa to the popliteal artery.Pre-dilation was performed using two balloons.Subsequent angiogram revealed, some elastic recoil with a filing defect noted in bypass graft distal to the area of angioplasty.A non-bsc stent was advanced to the area and deployed to trap the clot, which travelled further distally and occluded the peroneal artery.A non-bsc catheter was advanced into the peroneal artery and suction mechanical thrombectomy was performed to retrieve the clot.Subsequent angiogram revealed a spasm in the peroneal artery which was treated with a balloon with complete resolution.The proximal area noted to again have some recoil which was treated with the placement of a stent.The residual stenosis was noted 0%.On (b)(6) 2019, the event was considered to be 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9284518
• MDR Text Key: 165251509
• Report Number: 2134265-2019-13407
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2019

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: 0018349132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR