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

Model Number	24657
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was in-stent thrombosis and a potential stent fracture.A 6mm x 80mm, 130 cm eluvia drug-eluting vascular stent system was selected for use in an angioplasty and stenting procedure to treat thrombosis.On (b)(6) 2023, angioplasty was performed followed by successful deployment of the eluvia stent with a subintimal approach due to severe peripheral arterial disease.On (b)(6) 2024, the patient had a vascular lab follow-up where low parameters were noted, and the patient was referred to angiography.On january 10, 2024, angiography showed thrombosis inside the eluvia stent, and the physician suspected a possible stent fracture.Thrombo-aspiration was performed with a non-boston scientific device, and the thrombus was successfully removed.Additionally, a non-boston scientific stent and an innova stent were deployed inside the eluvia.No further patient complications were reported.
Event or Problem Description
It was reported that there was in-stent thrombosis and a potential stent fracture.A 6mm x 80mm, 130 cm eluvia drug-eluting vascular stent system was selected for use in an angioplasty and stenting procedure to treat thrombosis.On (b)(6) 2023, angioplasty was performed followed by successful deployment of the eluvia stent with a subintimal approach due to severe peripheral arterial disease.On (b)(6) 2024, the patient had a vascular lab follow-up where low parameters were noted, and the patient was referred to angiography.On (b)(6) 2024, angiography showed thrombosis inside the eluvia stent, and the physician suspected a possible stent fracture.Thrombo-aspiration was performed with a non-boston scientific device, and the thrombus was successfully removed.Additionally, a non-boston scientific stent and an innova stent were deployed inside the eluvia.No further patient complications were reported.It was further reported that the stent fracture was confirmed.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18544370
• Report Number: 2124215-2024-02725
• Device Sequence Number: 7923475
• Product Code: NIU
• UDI-Device Identifier: 08714729876595
• UDI-Public: 08714729876595
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030130197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown