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

Model Number 24657

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

Patient Problems Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Lot number: reported as 2735526.(b)(6).

Event Description

(b)(6) study.It was reported that thrombosis and embolism occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2022.The target lesion was in the left common femoral artery with 5.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length of 60 mm and 100% stenosis.The treatment of target lesion was performed by placing drug eluting stent of 6 mm x 120 mm.Following, the final residual stenosis was noted to be 5%.During treatment of target lesion, embolism and thrombosis were noted with residual stenosis was noted to be 5%.As a response to the event, thrombectomy was performed, and the complication was resolved.

Event Description

Elegance clinical study.It was reported that thrombosis and embolism occurred.The subject was enrolled in the elegance study on (b)(6), 2022.The target lesion was in the left common femoral artery with 5.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length of 60 mm and 100% stenosis.The treatment of target lesion was performed by placing drug eluting stent of 6 mm x 120 mm.Following, the final residual stenosis was noted to be 5%.During treatment of target lesion, embolism and thrombosis were noted with residual stenosis was noted to be 5%.As a response to the event, thrombectomy was performed, and the complication was resolved.

Manufacturer Narrative

A1 - patient identifier: (b)(6).E1 - initial reporter facility name: (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 MN ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13515794
• MDR Text Key: 286750954
• Report Number: 2134265-2022-01441
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• 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,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027235526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White