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

Model Number 22115

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

After opening, it was noticed that the thickness of the graft is not uniform in the 7m/m area.

Event Description

N/a.

Manufacturer Narrative

Related mdr: 3011175548-2023-00104 additional information: sections d9 & h6 investigation: the user reported that during a review of inventory they discovered two devices where the thickness of the graft was not consistent.Photos were provided and show the concern is with variation in wall thickness at the end of the grafts (one side appears thicker than the other).The product was in inventory at the time of the observation and was not used in any procedure or on a patient.The inventory review was conducted by the user due to the observation of a graft with variable wall thickness during a procedure (reference complaint (b)(4)).There were four devices found in the inventory review which were returned for evaluation.The other complaint associated with this series of returned product is 812500 and shares the same product lot number as this complaint.The other two device evaluations are complete under records 798134 and 798135.The returned devices were evaluated and are finished good code 22115 - 4-7x45 sw sh advanta vxt gds with product lot number 490089.The entire unused devices were returned for evaluation and showed no signs of having ever entered the surgical field.The returned grafts had no visible damage noted during the visual inspection of the device and the wall thickness was not concentric around the circumference of the graft.The tactile inspection per tp009431 did identify that the graft did not have a consistent feeling along the length and circumference due to the wall thickness not being concentric.The description of the event specified that there appeared to be a wall thickness discrepancy of the graft from one side to the other.This has been confirmed as this can be seen visually and felt tactically.The returned devices were tested for repeated puncture characteristic, suture retention testing, kink resistance, gds pull strength and longitudinal tensile strength.All results obtained passed the requirements.The wall thickness of the graft was also measured using a drop gauge following tp009546 rev 00.Measurements were taken in 4 locations around the circumference including the thinnest visible wall of the graft on both grafts samples.The top assembly part specification ps001095-xxx-xxx top, vxt, sw, stpr revision an calls out that the small end of the graft have a wall thickness ranging from.020 to.029 inches and the large end have a wall thickness range within.016 to.028 inches.The thinnest wall thickness observed was on the large end of the graft and was recorded as.0152 inches.The next thinnest measurement was.0157 inches also taken on the large end of the graft from complaint 812500.These two measurements of the eight measurements taken were the only data points below the requirement.The wall that was visualized as thinner was confirmed to be thinner with the wall thickness measurements, further confirming the complaint.The wall thickness of the graft in question is not conforming to the part specification drawing 001095-xxx-xxx and the grafts are considered nonconforming to the wall thickness requirements.A review of the finished good lot device history records as well as all sub assembly lots show that the grafts passed all quality and performance requirements during the manufacture of the product.There were no nonconformities identified that could be related to the complaint and there is no evidence that procedural or specification changes that occurred surrounding the time of the build could be related to the complaint.There is no indication of a nonconformity with this lot of grafts.It is important to note that wall thickness is not measured at the top assembly or finished good level.A complaint history, complaint trend, recurring lot number and capa review did identify 5 related complaints for the same product code.Four of the five complaints were received from the same institution that reported this complaint.All the complaints are confirmed and the root cause was listed as either user preference or related to manufacturing with a contributing factor related to design.The lot number was found to be recurring as it is associated with another complaint related to wall thickness variation (812500).Also, an associated capa was identified.The capa is 830110 and was opened for confirmed complaints and complaint trending escalation criteria being met for complaints related to wall thickness variation.The investigation for this complaint identifies that the manufacturing process allows variation in the wall thickness.However, the wall thickness measurements obtained on the parts do not meet the part specification 001095-xxx-xxx top, vxt, sw, stpr revision am for wall thickness.There is no in process control to detect grafts with non conforming wall thicknesses.The tactile inspection performed on the returned devices also indicated that they should not have passed the tactile inspection performed in process per tp009431.Additionally, there was information obtained during the investigation that the specifications on the drawing may not be comparative with the wall thickness results obtained from the drop gauge wall thickness test method measurements, pointing to a potential deficiency in the design requirements.In this regard the root cause is related to manufacturing with a contributing factor related to design.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.The labeling review determined that the instructions for use are appropriate as there are clear warnings and usability instructions related to use of a device that appears damaged.As the wall thickness of the graft in question is not conforming to the part specification drawing 001095-xxx-xxx, does not pass the tactile inspection, and there is information suggesting that the specifications on the drawing may not be comparative with the wall thickness results obtained from the drop gauge wall thickness test method measurements, this complaint and associated complaint is covered under capa 830110.

• 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
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 16841453
• MDR Text Key: 314265226
• Report Number: 3011175548-2023-00102
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862221152
• UDI-Public: 00650862221152
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K992960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22115
• Device Catalogue Number: 22115
• Device Lot Number: 490089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1