MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA SLIDER GDS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	22221
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	08/11/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient was hospitalized following a fall.Examination revealed cold, mottled limbs with no pulses, and angiography confirmed thrombosis of advanta graft.The patient died.
Additional Manufacturer Narrative
Due to character restrictions in block e1; event site name: (b)(6).A follow-up report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: a2, a4, b4, g1, g3, g6, h2, h6, h11 a follow-up report will be submitted upon completion of our investigation.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: h6.Corrected information: d4- model number.This pmcf registry complaint involves an advanta vxt graft implanted during a femorofemoral bypass procedure.The procedure was completed successfully, and the patient was discharged without complications.The patient later in 2025 developed severe limb ischemia, and imaging revealed thrombosis of the graft.Due to the patient¿s condition and comorbidities, revascularization, thrombectomy, and amputation were not feasible, and the patient was transitioned to palliative care, passing away in 2025.The investigator attributed the event to patient comorbidities rather than the device.The device was not returned and no images were available.Thrombosis may result from various procedural and patient-related factors, including vessel injury, flow disturbances, foreign body response, anastomotic technique, graft kinking or twisting, and hemodynamic conditions.The graft functioned as intended for several years post implantation, and the patient had multiple risk factors for thrombosis.Additionally, the procedure involved use in a high mobility anatomical location contraindicated in the ifu, which may have contributed.A device nonconformity cannot be confirmed.A dhr review was completed and did not identify any nonconformances related to this complaint in manufacturing.There is no indication that manufacuting is the cause of this complaint.The ifu provides adequate instructions for device use, including guidance on proper handling and cutting techniques, and clearly contraindicates use in axillofemoral or axillobifemoral bypass and other high mobility locations.There is no indication that the ifu contributed to this complaint.Complaint trending determined that the actual occurrence level did not exceed the anticipated occurrence level.No manufacturing, design, or labeling issues were identified, and complaint trending showed no adverse trends.The complaint could not be confirmed, and the most probable cause is considered a user-related anticipated procedural complication in combination with patient comorbidities.
Event or Problem Description
Preparation for fasciotomy of both legs prior to thrombectomy was initiated; however, the muscle tissue was observed to be sluggish, discoloured, and non-viable.Based on these findings, the planned procedure was cancelled.
Additional Manufacturer Narrative
Due to character restrictions in block e1.Initial reporter: (b)(6).Addiitonal information: a1, a2, a3, b5, b7, e1, g2.

• Brand Name: ADVANTA SLIDER GDS
• 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: 25078977
• Report Number: 3011175548-2026-000005
• Device Sequence Number: 10425037
• Product Code: DSY
• UDI-Device Identifier: 00650862222210
• UDI-Public: (01)00650862222210(17)230724
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/23/2026

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 Expiration Date: 07/24/2023
• Device Model Number: 22221
• Device Catalogue Number: 22221
• Device Lot Number: 462051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 05/06/2026; 06/19/2026; 06/19/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/25/2026; 06/19/2026; 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2020
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG