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

Model Number 22012

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the layers of the graft detached after trimming.

Event Description

N/a.

Manufacturer Narrative

Analysis: an examination of the returned device shows that the outer layer of the graft had started to unravel when the material was being pulled back as described in the complaint details.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.1.Hold the graft flat (horizontal).2.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.3.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.

Manufacturer Narrative

As the device in question was not returned an investigation into the root cause could not be conducted.The ifu states the following: ¿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 steps to do so are as follows: 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.¿ conclusion: based on the review of the device history records and product complaint details atrium can find no fault with the device in question.The method in which the helix was removed and the failure to draw the helix off the graft (secured horizontally) at a 45° angle in a slow and consistent manner led to degradation of the graft.Device not returned.

Event Description

N/a.

• Brand Name: GRAFTS ADVANTA VXT W/GDS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9119288
• MDR Text Key: 165588328
• Report Number: 3011175548-2019-01039
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862220124
• UDI-Public: 00650862220124
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: 22012
• Device Catalogue Number: 22012
• Device Lot Number: 443538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 10/28/2019; 12/17/2019
• Supplement Dates FDA Received: 10/29/2019; 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention