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 Arteriosclerosis/ Atherosclerosis (4437); Thrombosis/Thrombus (4440)

Event Date 02/15/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

Imperial clinical trial.It was reported that stent thrombosis occurred.On (b)(6) 2016, the subject was enrolled in the imperial study and the index procedure was performed on the same day.The target lesion #1 was located in the left mid superficial femoral artery (sfa) with 100 % stenosis and was 135 mm long with a proximal reference vessel diameter of 5 mm and distal vessel diameter of 5 mm and was classified as tasc ii b lesion.The target lesion #1 was treated with pre-dilation and placement of a 6.0 mm x 150 mm study stent.Following post-dilatation, residual stenosis was 0%.Subject was discharged on dual antiplatelet therapy.On 15-feb-2022, the subject visited the hospital for study specific 60 month follow up.On evaluation, subject was noted with short distance claudication with rutherford category 3 in the left leg (st/005).Subject also had rutherford category 3 claudication in the right leg.Subsequently, on the same day, doppler ultrasound was performed bilaterally, which revealed left leg patent common femoral artery with some calcification, stenosis in proximal profunda femoris artery with increased velocity to 588 cm/s, occlusion in stent and remaining part of superficial femoral artery, reconstituted popliteal artery from mid segment but with damped flow and patent tibial peroneal artery, anterior tibial artery, peroneal artery, and posterior tibial artery.Doppler ultrasound performed bilaterally, also revealed right leg patent external iliac artery, patent common femoral artery (cfa) with moderate calcific plaque, patent profunda femoris artery, cfa to popliteal bypass, velocity noted at graft increased from 61 cm/s to 152 cm/s and ratio of 2.5, occlusion in mid to distal popliteal artery and tibial peroneal trunk.In response to the event no action was taken, and the event was considered not recovered/not resolved at this time of report.

• 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: 14517394
• MDR Text Key: 292795579
• Report Number: 2134265-2022-05992
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• 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: 0018822233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White