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 Problem Obstruction/Occlusion (2422)

Event Date 11/20/2018

Event Type  Injury  

Event Description

(b)(6) clinical trial.It was reported that a vessel occlusion occurred.The patient underwent treatment with the eluvia device on (b)(6) 2017 as part of the regal clinical trial.The following lesion was treated in the left limb: proximal, middle and distal superficial femoral artery (proximal popliteal artery not involved).The lesion was 220mm long, 100% stenosed with a proximal reference diameter of 6mm and distal reference diameter of 5mm.Pre-dilatation was performed using a balloon and the lesion was crossed through the true lumen.Three eluvia drug eluting vascular stents 6mm x 100mm, 6mm x 80mm, and 6mm x 80mm were implanted in the target lesion.Post-dilatation was performed using one balloon.The residual stenosis was 0% and there was no thrombus seen in the treated vessel at the end of the procedure.On (b)(6) 2018, an occlusion in the target vessel was discovered.The patient was hospitalized on (b)(6) 2018 for a percutaneous transluminal angioplasty treatment with a drug eluting balloon at the deep left femoral artery.The patient was discharged on (b)(6) 2018 and the event is reported as resolved with sequelae.

Manufacturer Narrative

Patient identifier: (b)(6).Initial reporter facility name: (b)(6).Initial reporter phone: (b)(6).

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13745594
• MDR Text Key: 287910857
• Report Number: 2134265-2022-02569
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 03/11/2022

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: 01/17/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020993693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Sex: Male