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

Model Number	22115
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported that during rinsing before avf surgery, and as a result of preliminary experiments through blood vessels by extracting the patient's blood before surgery at that time, stenosis occurred due to the remarkably thin blood vessel thickness on one side.One side of the thin side is not maintained in the form of a tube, and the other side is shrunk.Procedure completed with another device same model.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The details of the complaint were the following "as a result of preliminary experiments through blood vessels by extracting the patient's blood before surgery at that time, stenosis occurred due to the remarkably thin blood vessel thickness on one side.One side of the thin side is not maintained in the form of a tube, and the other side is shrunk." follow up questions were asked to clarify the complaint.The gfe responses indicated that the term ¿thin side¿ is being used to reference the 4mm end of the graft.Additionally, the side of the graft that was described as ¿shrunk¿ was on the 4mm end of the graft.The experimentation was done table side.Based on the details of the complaint and the gfe answers received, it is believed that the complaint is surrounding the wall thickness of the graft and the possibility that the graft did not appear to be concentric on the 4mm end of the graft.The device in question has been returned for evaluation.The graft is a tapered 4-7x45 sw nh advanta vxt gds product code 22115.The graft was blood stained on the outside of the graft however the inside was clean and did not show signs of having blood contact.The 4mm section of the graft was in good condition and did not appear to be damaged and the wall thickness of the graft appeared to be very even and was also not damaged.The larger 7mm end of the graft had been cut.The gds (which should have been connected to the 7mm end of the graft) was also provided but was not attached to the end of the graft.The cut 7mm end was found compressed and thus the graft did not appear round when viewed axially.When the graft was gently compressed to facilitate opening of the graft end, the wall thickness was observed to be larger on one side than on the other, see the attached picture.The inner diameter of both ends of the graft were measured using tp009437.The 7mm diameter end of the graft was measured to be 0.2685in while the 4mm end of the graft was measured to be 0.144in.Both ends are within the specifications of 0.256-0.295in for the 7mm end and 0.138-0.177in for the 4mm end.The graft was tactile inspected using the method defined in tp009431 to detect any variation in stiffness, hard rings or soft spots.No abnormalities were found.The length of the graft was measured to be 51 cm long and is within the length specification of 51cm ±3cm.There was no shrinkage of the graft identified.The report of one side of the 4mm end of the graft being shrunk and the other side not being in the form of a tube cannot be confirmed.A review of the device history records show that this lot of grafts passed all quality and performance requirements and that there were no non conformances during the manufacture of the product.The samples tested as part of the in process testing and lot qualification testing passed the requirements for radial tensile strength (rts), longitudinal tensile strength (lts), suture retention strength (srt), and the inner diameter of both the small and large ends of the grafts.There is no indication of a nonconformity with this lot of grafts.Testing of the 7mm end of the returned device was performed to understand if the results for this specific graft are in alignment with the samples tested in the lot.Since the graft had been in contact with blood, testing was limited to the tests that could be performed outside of the clean environment and without the use of production equipment.Srt and lts testing were the available tests.Lts testing requires clamping both ends of the graft and applying a longitudinal pull within a tensile testing machine.Since the portion of the graft with the thinnest wall thickness would be clamped, the results would not be indicative of the strength of the thinnest wall of the graft.Therefore, srt was chosen as the test to perform.A section of the 7mm end of the graft (which is the end where the wall thickness of the graft is thinnest) was tested per procedure tp000511 tp, graft top assy, srt revision az.Four data points were taken radially around the circumference of the graft.One of the four points was placed directly in the part of the graft wall that was visually assessed as the thinnest.The results show that out of the 4 sutures pulled out of the graft the minimum force of removal was 1.58lbf.Per the part specification document ps001095-xxx-xxx top, vxt, sw, stpr revision am the lowest acceptable force value is 0.6lbf.This value was exceeded and is in line with the samples tested as part of the lot qualification testing as seen in the top assembly device history records, 474316 and 473637.The minimum suture retention force from both device history records, with a total of 104 suture retention data points, was 1.09lbf.Additionally, as part of the investigation into the wall thickness differences observed on the 7mm end of the graft, a graft¿s subject matter expert (sme) was consulted.The sme indicated that the concentricity of the graft wall thickness is controlled by the base graft extrusion process, specifically how the insert die is installed into the master die chamber.A review of the graft base material, flat stock, top assembly and finished goods device history records did not identify any nonconformities.All in process and final inspections passed.Based on the details of the complaint and investigation of the returned device neither a nonconformance with the product nor the complaint itself can be confirmed.The product met all quality and performance requirements.The root cause is a user preference issue.The labeling review determined that the instructions for use are appropriate as there are clear warnings and usability instructions for the proper preparation of the graft.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.

• Brand Name: GRAFTS ADVANTA VXT W/GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 14140816
• Report Number: 3011175548-2022-00125
• Device Sequence Number: 4001281
• Product Code: DYF
• UDI-Device Identifier: 00650862221152
• UDI-Public: 00650862221152
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2024
• Device Model Number: 22115
• Device Catalogue Number: 22115
• Device Lot Number: 473403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown