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

Model Number 22209

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event 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.

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 Description

N/a.

• Brand Name: ADVANTA VXT, 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: 8087728
• MDR Text Key: 127934365
• Report Number: 3011175548-2018-01316
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862222098
• UDI-Public: 00650862222098
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K992960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 80 YR