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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient identifier: (b)(6).Age at time of event: patient was 68 years old at the time of study enrollment.
Event or Problem Description
It was reported that the patient expired due to unknown etiology.On (b)(6) 2021, the patient underwent treatment with three eluvia drug eluting stents as a part of a clinical study.The target lesion was located in the right proximal superficial femoral artery (sfa), mid sfa, distal sfa and right proximal popliteal artery.The target lesion had a proximal reference vessel diameter of 5.1 mm and distal reference vessel diameter of 4.6 mm.The target lesion was 90 percent stenosed and 300 mm in length, and was classified as tasc ii c lesion.Treatment of the target lesion was performed by placement of three eluvia drug eluting stents of 6.0 mm x 120 mm, 6 mm x 100 mm, and 6 mm x 80 mm.Following stent placement, post dilation of the target lesion was performed with 5 mm x 200 mm and 5 mm x 80 mm mustang pta balloon.The final residual stenosis was noted to be zero percent, and there were no reported adverse consequences to the patient.The following day, the patient was discharged with aspirin.On (b)(6) 2022, while attempting to schedule a 6-month follow-up appointment, the study site was informed by the patient's family member that the patient had expired at some point following (b)(6) 2021.The exact date of death was unknown.No information was provided regarding the patient's cause of death, the relationship to covid-19, or the relationship to the eluvia stents and the index procedure.It was unknown whether an autopsy was performed.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: 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: 16018715
• Report Number: 2124215-2022-51847
• Device Sequence Number: 14917543
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027040255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female
• Patient Race: Black Or African American