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

Model Number	22075
Health Effect - Clinical Code	Death (1802)
Date of Event	04/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).On completion of the investigation a follow up report will be submitted.
Event or Problem Description
The physician reported he was performing a femoral-popliteal bypass on a patient that resulted in the patient having excessive bleeding from the popliteal vein.The patient became hemodynamically unstable and was transferred to the intensive care unit.He expired on (b)(6) 2016 of multi-organ failure.
Additional Manufacturer Narrative
Engineering investigation: the graft was not returned for investigation.Summary of event: the physician reported an adverse event with a femoral-popliteal bypass procedure.He used an atrium ptfe graft.As he was closing the patient had a significant venous bleed from the distal exposure site.Engineering analysis: a complete review of the lot history was performed.The lot history of the graft was found to have met all specifications.Engineering summary: no issue with the graft could be identified.Conclusion: based on the details of the event atrium can find no fault with the lot of grafts in question.Clinical evaluation: the patient that requires a vascular graft does not have normal vascular tissue.The tissue may be hardened and calcified or very friable.Grafts are implanted surgically via an open incision and/or sub-cutaneous tunneling in certain applications.Surgeons undertaking such procedures are specialists in vascular disease and surgery and they have the skills necessary to be working in an operative suite and are supported by trained staff.It was reported that the patient experienced a loss of blood during implantation of the graft which the physician attributes to the tunneler tip.The instructions for use state: "complications that may occur in connection with the use of any vascular graft include, but are not limited to, thrombosis, infection and blood loss.".
Additional Manufacturer Narrative
Mdr report 3011175548-2016-00006 was created in error please disregard the report.

• Brand Name: ATRIUM ADVANTA VXT VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack, NH 03051
• MDR Report Key: 5825295
• Report Number: 1219977-2016-00166
• Device Sequence Number: 341918
• Product Code: DSY
• UDI-Device Identifier: 00650862220759
• UDI-Public: 00650862220759
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2016

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: Physician
• Device Expiration Date: 02/17/2019
• Device Model Number: 22075
• Device Catalogue Number: 22075
• Device Lot Number: 404688
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2016
• Supplement Date Received by Manufacturer: Not provided; 04/03/2020
• Initial Report FDA Received Date: 07/27/2016
• Supplement Report FDA Received Date: 08/11/2016; 04/07/2020
• 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: Death
• Patient Age: 76 YR