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

Model Number	22209
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2018
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 while trying to remove the rings of the graft, the graft came with the rings.The patient is stable.The procedure was a fem to fem bypass connecting the right femoral to the left femoral.It was the second time the physician had used the advanta graft.He usually uses a different product extensively.
Additional Manufacturer Narrative
Analysis: the graft in question was not returned for evaluation.As specified in the instructions for use: ¿if the external support rings are pulled too quickly, it is possible for a small portion of the vxt outer wrap to be removed.Should the outer wrap fray, the physician is still left with the base layer, which will be sufficient to complete the procedure.¿ a device history record review was performed and the graft lot was found to have met all specifications.While the rings are added to the advanta vxt to improve kink, compression and torque resistance, a physician may choose to remove portions of it for surgical/technical reasons.The instructions for use (ifu clearly define the appropriate steps of removing the helix.Hold the graft flat (horizontal).Take the very distal portion of the ptfe ring with a pair of forceps and slowly pull off the ring at a 45 degree angle.Being mindful not to catch the outer soft wrap.If the external support rings are pulled too quickly, it is possible for a small portion of the vxt outer wrap to be removed.Should the outer wrap fray, the physician is still left with the base layer, which will be sufficient to complete the procedure.Clinical evaluation: an arterio-venous (av) graft is a looped, synthetic tube that connects an artery to a vein.Advanta eptfe vascular grafts are intended for use in arterial vascular reconstruction, segmental bypass, and for arterio-venous vascular access.A graft may delaminate due to incorrect length, excessive tension or if implanted in a location that has excessive movement.The ifu states that the advanta vxt grafts should only be cut and trimmed with sharp surgical instruments to avoid reinforcement layer disruption.
Event or Problem Description
N/a.

• Brand Name: ADVANTA VXT, GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8087728
• Report Number: 3011175548-2018-01316
• Device Sequence Number: 1225300
• Product Code: DSY
• UDI-Device Identifier: 00650862222098
• UDI-Public: 00650862222098
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 10/20/2020
• Device Model Number: 22209
• Device Catalogue Number: 22209
• Device Lot Number: 420860
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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: 80 YR