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

Model Number 22220

Device Problems Detachment Of Device Component (1104); Structural Problem (2506)

Patient Problem Blood Loss (2597)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When placing the graft the physician noticed the outer coating of the graft was pulling away from it when the plastic rings were being removed for implant.The areas where the coating was coming away from the graft had increased bleed through areas and needed extra support and patching to reduce leakage.The physician did extreme patching of the graft in the areas that were leaking or had the potential to leak.Outcome: successful, no bleeding.

Manufacturer Narrative

Analysis: the graft in question was returned for evaluation and examined.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
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7486353
• MDR Text Key: 107573755
• Report Number: 3011175548-2018-00431
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K992443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 71