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 Problems Pain (1994); Thrombosis (2100)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled into the eminent study on (b)(6) 2017 and the index procedure was performed on the same day.The target lesion was located in the right mid to distal superficial femoral artery (sfa) and had 100% occlusion, a proximal reference vessel diameter of 5.5 mm, a distal reference vessel diameter of 5.5 mm, and a length of 70 mm.The lesion was classified as a tasc ii b lesion.The target lesion was treated with pre dilatation and placement of a 6 x 100 mm study stent.Post dilatation was performed with 5 % residual stenosis.On (b)(6) 2017, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2018, the subject started experiencing pain in the right leg.On (b)(6) 2018, the subject presented due to worsening pain in the right leg and an inability to walk.It was noted that the day prior, the subject had clamminess, sweating, and dizziness.Duplex imaging of the arteries of the right leg revealed, low flow in the common femoral artery, filiform open lumen proximal in the sfa over a length of 2 cm, and further complete occlusion of the sfa.Irrigation of the leg via the posterior fibular artery (pfa), reperfusion proximal in the popliteal artery (a little before the origin of the suralis artery), and otherwise normal accessible popliteal artery with very low flow was observed.At the level of the ankle, very low flow is demonstrated in the arteries.On the same day, the right sfa was treated with ultrasound guided thrombolysis with 50% residual stenosis.On (b)(6) 2018, the mid-grade thrombosis stenosis in mid stent and high-grade stenosis in the ostial pfa was treated with balloon dilatation using a non-bsc 5 x 80 mm balloon with 10% residual stenosis.On the same day, event was considered recovered and resolved.On (b)(6) 2018, subject was discharged on aspirin and clopidogrel.

• 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
• 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: 9856436
• MDR Text Key: 184164806
• Report Number: 2134265-2020-03602
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• 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: 0019635396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2016
• 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: 73 YR