MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION STENTS I-CAST; ILIAC COVERED STENT, ARTERIAL

Model Number	42722
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Distributor rep states: during an aneurysm repair procedure while advancing the balloon over the wire through a fenestration in the graft.The balloon got caught and would not pass through the fenestration.When they removed it, the icast stent had dislodged from the balloon.Nobody realized this until the balloon was removed from the system.The stent was floating around in the aa.They snared the stent and removed it from the patient.The procedure was successfully completed with another device of the same type.A day later it was confirmed that the patient was doing great.The rep confirmed that the balloon was never inflated.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected information: section d2b - procode.Additional information: section d10.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Investigation summary: distributor rep states: during an aneurysm repair procedure while advancing the balloon over the wire through a fenestration in the graft.The balloon got caught and would not pass through the fenestration.When they removed it, the icast stent had dislodged from the balloon.Nobody realized this until the balloon was removed from the system.The stent was floating around in the aa.They snared the stent and removed it from the patient.The procedure was successfully completed with another device of the same type.A day later it was confirmed that the patient was doing great.The rep confirmed that the balloon was never inflated.Additional information provided through gfe indicate the procedure was a 4 vessel fevar procedure and the target was the celiac artery.The introducer sheath used in the case was a medtronic steerable tour guide sheath.The angle going into the celiac artery off the aorta was a 90 to 70 degree angle.The returned device was evaluated, and the stent was no longer on the balloon and was in very poor condition as it had been snared and removed from the aorta.The balloon of the catheter had a very large curve to it from navigating to the celiac artery.The bend is indicative of a device that was attempted to navigate an acute angle such as the angle associated with the celiac artery.This is in line with the detail provided that the ¿angle going into the celiac artery off the aorta was a 90 to 70 degree angle¿.Atrium medical corp.Has not tested or evaluated the icast covered stent for use in the celiac artery.The surface of the balloon shows that the impressions of the stent frame are very clear.These impressions of the stent frame are indicative of a properly crimped stent from manufacturing.To ensure there was no other damage, the catheter was prepped per the instruction for use and the balloon pressurized to the rated burst pressure of 12 atm as indicated on the product label.The balloon opened without issue and the entire catheter showed no signs of leakage.As the procedure had been a 4 vessel fevar procedure there is a possibility that the fenestration ring of the endograft was not properly aligned with the celiac artery in this case.There is also the possibility that the sheath in the case kinked or was at such an angle and further attempts to put the stent through the fenestration ring were met with a large amount of resistance.In either scenario it is clear the stent was outside the distal end of the tour guide introducer sheath.If the stent was attempted to be withdrawn back through the sheath it is likely the stent caught the end of the tip of the introducer sheath, pushing the undeployed stent off of the balloon.As it was stated in the correspondence: "when they removed it, the icast stent had dislodged from the balloon.Nobody realized this until the balloon was removed from the system.The stent was floating around in the aa." this detail does indicate that the undeployed stent was attempted to be removed back through the introducer sheath.If fluoroscopic images were provided this may have been able to be confirmed.Images were requested but not provided.Based on the complaint details and returned device evaluation there is no evidence to suggest that the icast covered stent was the cause of the complaint.Being that the device could not pass through the fenestration and into the celiac artery suggests that the fenestration ring of the endograft may not have been properly aligned with the target vessel.As the device was likely removed back through the sheath against the instructions for use the complaint root cause is related to the operational context of the procedure related to operator error in this case.There is no evidence that the manufacture of the device is related to the inability of the catheter to access the celiac artery.The review of the device history records shows that this lot of icast covered stent catheters passed all quality inspection including the insertion of the catheter through the appropriately sized (7fr) introducer sheath without stent movement.A recurring lot number query was conducted and there has been no other complaints associated with this lot of stent delivery systems (l/n 505105).A review of the complaint trending did not identify any excursions for the reported defect.Based on the information provided in the complaint, there is no evidence to conclude that the device was faulty or manufactured improperly.Based on the investigation, the root cause is operational context as the target was the celiac artery in conjunction with a fenestrated aortic endograft.
Event or Problem Description
N/a.

• Brand Name: STENTS I-CAST
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• 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: 19942864
• Report Number: 3011175548-2024-00207
• Device Sequence Number: 7414148
• Product Code: PRL
• UDI-Device Identifier: 00650862427226
• UDI-Public: (01)00650862427226(17)270110(21)505105000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2024
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 42722
• Device Catalogue Number: 42722
• Device Lot Number: 505105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 08/12/2024; 08/29/2024; 09/30/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/12/2024; 08/30/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7.5FR MEDTRONIC TOURGUIDE; MEDTRONIC STEERABLE TOURGUIDE SHEATH
• Patient Age: 81 YR
• Patient Sex: Male