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

Model Number 22220

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

After the ringed external support on the vxt graft was removed, the graft outer layer began to rip off.

Manufacturer Narrative

Analysis: the graft in question was not returned for evaluation.There were a total of three images provided of the graft.Based on the images provided the outer layer of the graft was fraying.The ptfe ring had been pulled and the outer soft wrap had begun to fray.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 he 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 crafts should only be cut and trimmed with sharp surgical instruments to avoid reinforcement layer disruption.

• Brand Name: ADVANTA VXT W/GDS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7398573
• MDR Text Key: 104849792
• Report Number: 3011175548-2018-00312
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K992960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2019
• Device Model Number: 22220
• Device Catalogue Number: 22220
• Device Lot Number: 410008
• Other Device ID Number: 00650862222203
• Device Age: YR
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention