MAUDE Adverse Event Report: Atrium Medical Corporation ADVANTA; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Model Number	21000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury

• Brand Name: ADVANTA
• Common Device Name: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• Manufacturer (Section D): Atrium Medical Corporation; 40 continental blvd; merrimack NH
• Manufacturer (Section G): Atrium Medical Corporation; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 50745765
• Report Number: 3011175548-2026-000010
• Device Sequence Number: 15992469
• Product Code: DSY
• UDI-Device Identifier: 00650862210002
• UDI-Public: (01)00650862210002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K231972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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 Model Number: 21000
• Device Catalogue Number: 21000
• Device Lot Number: 517570
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/12/2026
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 165 LB