MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION I-CAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85455

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report received stated that the catheter buckled on itself when trying to get balloon into vessel at a difficult angle.The physician thinks the angle was very difficult to maneuver and was putting a lot of pressure on the device.

Event Description

N/a.

Manufacturer Narrative

The details provided about the alleged incident were the following: catheter buckled on itself on trying to get balloon into vessel at a difficult angle.Additional information received: dr.Beck who was the physician thinks the angle was very difficult to maneuver and was putting a lot of pressure on the device.He was not overly concerned about the event.The described event based on the provided information was a four vessel fenestrated aortic repair.The returned device was evaluated upon receipt.The catheter shaft was very badly damaged from the force applied while trying to advance the catheter through the fenestration of the endograft and into the renal artery.For the catheter shaft to have been compressed and damaged to this degree with a guidewire in place suggests that a tremendous amount of force was applied during the process of advancement of the catheter.The stent was no longer on the balloon and had been dislodged from its location between the radiopaque ro marker bands.The stent was clearly bent in the center of the stent from the angulation trying to be overcome during the attempted advancement into the renal artery.The cover of the stent was in good condition and was not damaged.The surface of the balloon was in good condition and showed that the stent was properly crimped.When the stent is crimped onto the balloon during the manufacturing process, the stent frame leaves very defined imprints on the surface of the balloon.The imprints were very visible on the balloon surface of the returned device.The balloon shoulders/cones that are not under the stent once crimped were in good condition and were not damaged.The distal tip of the catheter was also in good condition and showed no signs of damage.The complaint can be confirmed, as the investigation did confirm the described damage imparted during the clinical procedure.The evaluation of the returned device did not reveal any indication that the device in question was faulty or manufactured improperly.A dhr review was completed which did not find any non-conformances during the manufacturing process of this lot that were related to this complaint.Complications that could be experienced during this type of procedure is proper alignment of the fenestration of the endograft with the renal artery.If the fenestration were not aligned properly, the catheter would not be able to be advanced into the renal artery.From a manufacturing standpoint the product¿s ability to be tracked over the guidewire lumen is and was the area of focus as if the catheter wasn't able to be tracked over the guidewire it is possible to damage the catheter as seen with the returned product.The review of the dhr and the 200% guidewire patency inspection conducted during the product build without any rejects for wire patency indicates that this was not likely the issue.The device met all specifications and was being used for treatment at the time of the incident and the device in question does not appear to be the contributing factor in the cause of the complaint.In this regard, the most likely cause of the complaint is operational context.The trend review was completed which did identify one excursion for the reported defect within the months of december 2020 and january 2021 for the advanta v12 product line.This was escalated per cr434060, but did not initiate a capa due to the events being unrelated.No other capa requests or capas were found to be related to this event.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: I-CAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 11175549
• MDR Text Key: 228193159
• Report Number: 3011175548-2021-00043
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854558
• UDI-Public: 00650862854558
• Combination Product (y/n): N
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: 85455
• Device Catalogue Number: 85455
• Device Lot Number: 464137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2020
• 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