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

Model Number 22114

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

When dilated at 14 atm using a 6 mm balloon pta, the artificial blood vessel ruptured in the long axis direction.

Manufacturer Narrative

The device was returned and consisted of a less than 2"inch segment of the graft that had a longitudinal tear approximately 2.0 cm long.The graft that was used in the procedure was a graft that was tapered from 4mm to 6mm.The segment returned was measured to be the section that was still in the 4mm tapered section as the inner diameter of the graft both proximal and distal to the tear in the graft was 4.7mm.Being that the balloon used was a high pressure 6mm balloon it is not surprising that the eptfe split.The details state that the pressure used was 14 bar or 203 psi.If the balloon had been deployed in the 6mm section of the graft this split of the material would not have been likely.The instructions for use (ifu) state the following in regards to performing a thrombectomy: "thrombectomy: in the event that an incision needs to be made to the advanta vxt or flixene graft (e.G.For the purpose of providing an access site for declotting the distal anastomosis) post implantation, the following is recommended: "do not apply excessive tension on the implanted advanta vxt or flixene eptfe graft during inflated balloon catheter withdrawal.Over inflation of an embolectomy balloon or use of an inappropriate sized catheter may cause damage to the graft and anastomosis." a thrombectomy balloon catheter is a very low pressure highly compliant balloon typically inflated by volume and not pressure.Based on the details of the complaint the balloon used was a high pressure pta catheter as 14 bar was achieved.Every graft assembly goes through a 100% tactile and visual inspection.If defects are found in the material, the section of material is removed from the length of graft being inspected.Holes of any kind are rejected.Additionally the top assembly for the advanta graft has a requirement for the radial tensile strength of the eptfe tubing.Per the advanta vxt product requirements document the minimum radial strength of the graft shall be 25lbf for all sizes.The review of the device history records show that the minimum rts value was 108lbf.This exceeds the 25lbf requirement.The review of the device history records show that there were no non-conformances during the manufacture of the product.Based on the details of the complaint, review of the physical product and device history records review the root cause of the split in the graft was caused by user error.The split was in the 4mm section of the graft and was caused by the use of a 6mm high pressure balloon in the 4mm location of the graft.

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: 10744890
• MDR Text Key: 213377814
• Report Number: 3011175548-2020-01307
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862221145
• UDI-Public: 00650862221145
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: 22114
• Device Catalogue Number: 22114
• Device Lot Number: 455465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention