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

Model Number	22114 - 4-6X45 SW SH ADVANTA VXT GDS
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported that sweating occurred in the graft during arterio-venous graft surgery.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Analysis: the details indicate that the advantage grafts had sweating or weeping when flushed with saline.Upon receiving the device back for investigation the graft was inspected for visible damage.The graft had been cut into two (2) separate pieces.No other damage was noted.There were no signs of suture or clamp marks on the graft.As the instructions for use specify, the graft should not be wetted prior to use or force aqueous solutions through the graft wall.When saline or fluid is pressurized in the graft the porosity and structure will change.If saline was flushed through the graft without the device being clamped there would be no sweating or weeping as it would simply come out the other end.In this case for the graft to sweat or weep the graft would have had to been pressurized.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.A review of the test data indicates that this lot passed all the water entry pressure test requirements.Conclusion: atrium medical corporation had determined that the advantage vxt was performing properly prior to the graft being pressurized with saline.

• Brand Name: GRAFTS ADVANTA VXT W/GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9072346
• Report Number: 3011175548-2019-00980
• Device Sequence Number: 19435364
• Product Code: DYF
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2022
• Device Model Number: 22114 - 4-6X45 SW SH ADVANTA VXT GDS
• Device Catalogue Number: 22114
• Device Lot Number: 433984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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