MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	85445
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: add related report # to h10.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Investigation summary: the device in question was returned and evaluated to determine the cause of the complaint.Upon inspection the catheter was in good condition and was blood stained as the device had been inserted through a 7fr oscor twist steerable introducer sheath.The stent was still firmly in place between the two gold radiopaque marker bands.The stent did have minor deformation and lifting of the end cell of the stent at the distal end.The damage is indicative of a stent that made contact on one side with another object or obstruction.There was a slight curve to the balloon from attempting to navigate to the superior mesenteric artery.There was no visible damage to the tip of the catheter.The details provided indicate that this device was used in a four vessel fenestrated endovascular repair where and endograft was used and 8 stents were used.Multiple questions were asked of the user and not all questions were answered.Key elements to aid in the investigation were omitted such as if the fenestration was properly aligned with the target vessel, and if the vasculature was calcified or tortuous and if the device required excessive manipulation to track to the sma.Based on the condition of the stent on the distal end where there was deformation noted, it is likely that the stent became caught on the fenestration ring of the endograft prior to bridging into the target vessel of the sma.Atrium medical has not tested or evaluated the icast covered stent for use in the superior mesenteric artery.As the returned device was damaged at the end of the stent it is clear that the catheter met a solid blockage confirming the complaint however there is no evidence to conclude that the icast covered stent was the cause of the blockage or reason the product could not be placed at the target vessel of the sma.In cases such as this obtaining fluoroscopic imaging from the user is extremely beneficial.Films were requested but not provided.Based on the condition of the stent the stent likely got hung up on the edge of the fenestration ring or the endograft or the endograft itself may not have been properly aligned with the sma.In this regard the most probable root cause is the operational context of the procedure.A recurring lot number report was run on product lot number 503504 and this is the only complaint associated with this lot number.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
A medwatch report # (b)(4) was received stating: during an aorta, fenestrated endovascular repair of visceral and infrarenal aorta for delivery of endograft 12 fr or greater, the stent got caught on something and couldn't advance.Stent removed from patient and not used.

• Brand Name: ICAST
• Common Device Name: 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: 20290396
• Report Number: 3011175548-2024-000022
• Device Sequence Number: 8086059
• Product Code: JCT
• UDI-Device Identifier: 00650862854459
• UDI-Public: (01)00650862854459(17)261115
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2024

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 Model Number: 85445
• Device Catalogue Number: 85445
• Device Lot Number: 503504
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 11/04/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/07/2024; 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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: SHEATH 7.0FR OSCOR TWIST COMFORABLE.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 100 KG