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

Model Number	22114
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
After graft transplantation, there was inflammation.The user assumed that the problem occurred elsewhere rather than the graft problem.
Additional Manufacturer Narrative
Analysis: the details indicate that swelling occurred after the procedure and if other devices from the same lot had been reported for swelling issues.A review of our complaint log indicates that there have been no other complaints related to swelling from the same production lot of graft going back historically 3 years.A thorough review of the device history records for this graft lot was conducted.The device lot in question met all quality and performance testing requirements and no non-conformances were noted during the build of the product related to the complaint.The instructions for use in the adverse reaction section mentions the following in regards to complication with the use of any vascular graft include the following: ¿complications that may occur in connection with the use of any vascular graft include, but are not limited to; thrombosis, stenosis, formation of pseudoaneurysm due to excessive needle punctures, peri-graft hematoma formation, peri-graft seroma formation, excessive needle hole bleeding or weeping, infection, swelling of tissue, suture hole elongation, mechanical disruption, material separation, delamination or tearing of the graft material, suture line or host vessel which may result in extreme blood loss, loss of limb function, steal syndrome, loss of limb or possible death.The patient should be advised to contact the physician should an adverse reaction occur.¿ conclusion: based on the review of the device history records and product complaint details atrium medical corporation cannot conclude that the swelling was directly related to the advanta graft.

• Brand Name: ADVANTA VXT W/GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8910258
• Report Number: 3011175548-2019-00884
• Device Sequence Number: 525607
• Product Code: DSY
• UDI-Device Identifier: 00650862221145
• UDI-Public: 00650862221145
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2019

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: 04/10/2022
• Device Model Number: 22114
• Device Catalogue Number: 22114
• Device Lot Number: 443557
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/10/2019; 02/01/2021
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/17/2019; 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 61