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 Thrombosis/Thrombus (4440)

Event Date 05/14/2019

Event Type  Injury  

Event Description

(b)(6) clinical trial: it was reported that stent thrombosis occurred.The patient underwent treatment with the eluvia device on (b)(6) 2018 as part of the (b)(6)clinical trial.Treatment was performed in the left, mid and distal superficial femoral artery (proximal popliteal artery not involved) with 280mm length and 100% stenosis.Reference vessel diameters were 6mm proximally and distally.Pre-dilatation was performed using one balloon and the lesion was crossed subintimal.Two eluvia stents were implanted (6x120mm and 6x120mm).An additional stent was implanted (6x40mm, tigris, gore), because of residual stenosis.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2019, the patient experienced a target vessel occlusion.Stent thrombosis occurred in one of the eluvia stents.No further details regarding treatment or intervention were reported.The event was reported as resolved with sequelae as of (b)(6) 2019.

Manufacturer Narrative

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

Event Description

Regal clinical trial: it was reported that stent thrombosis occurred.The patient underwent treatment with the eluvia device on (b)(6) 2018 as part of the regal clinical trial.Treatment was performed in the left, mid and distal superficial femoral artery (proximal popliteal artery not involved) with 280mm length and 100% stenosis.Reference vessel diameters were 6mm proximally and distally.Pre-dilatation was performed using one balloon and the lesion was crossed subintimal.Two eluvia stents were implanted (6x120mm and 6x120mm).An additional stent was implanted (6x40mm, tigris, gore), because of residual stenosis.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2019, the patient experienced a target vessel occlusion.Stent thrombosis occurred in one of the eluvia stents.No further details regarding treatment or intervention were reported.The event was reported as resolved with sequelae as of (b)(6) 2019.Additional information was received that indicated the actions taken included hospitalization along with medication given or regimen adjusted.

Manufacturer Narrative

Initial reporter facility name e1: (b)(6).Initial reporter phone e1: (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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14219598
• MDR Text Key: 290165682
• Report Number: 2134265-2022-04156
• 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,Followup
• Report Date: 08/02/2022

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: 04/24/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021388754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Male