MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 5MMX22MMX120CM; ILIAC COVERED STENT, ARTERIAL

Model Number	42522
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block d10.Concomitant products- sheath 6frx55cm ansel, endograft port zdeg-pt-32-24-158.Upon completion of the investigation into this event a follow-up report will be submitted.
Event or Problem Description
It was reported that during the fenestrated endovascular aortic procedure, icast balloon ruptured before reaching 12atm pressure.However, the procedure was completed and the stent was able to be placed.There was no harm reported.
Additional Manufacturer Narrative
Additional information section: d9, h3 the customer reported that while deploying the icast stent before the balloon reached 12atm it burst, the stent was able to be placed.Another icast stent was used to make sure it was fully apposed.Upon review of the returned balloon a long longitudinal tear from the proximal balloon transition zone down to the distal end of the dilatation zone was noted confirming the complaint.To determine if there were any outside influences that may have caused this balloon rupture the balloon was inspected under 20x magnification.A large deep scratch was noted on the distal end of the balloon.It is noteworthy to mention that every balloon is 100% cosmetically inspected and pressure tested to the rated burst pressure of 12 atm during the process of manufacturing.Being that this large scratch was noted combined with the original detail provided suggests that the balloon was damaged on the physician modified endograft fenestration rings of the endograft.Based on the destructive nature of the burst with a longitudinal tear it is difficult to determine if any other scratches lead to the balloon rupture however based on the large scratch seen on the returned balloon surface this is the likely root cause of the balloon burst.A review of the device history records shows that there were no non-conformances noted and the product met all quality and performance requirements.There is no indication that a design, manufacturing specification, test method, manufacturing process, equipment or raw material was the cause of the complaint.A recurring lot number query was conducted for l/n 516636 and there have been no other complaints associated with the production lot of finished goods.A historical review of capa and ncrs was completed, which did not identify any issues directly related to this complaint.A complaint history review did identify several related complaints involving balloon burst, which were associated with procedure complications that resulted in the rupture of the balloon of the catheter.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.Based on the device evaluation, a long longitudinal tear from the proximal balloon transition zone down to the distal end of the dilatation zone was noted confirming the complaint.However, the details of the complaint and investigation findings conclude there is no evidence to suggest that the balloon was defective when manufactured.The balloon was most likely damaged on the physician modified endograft fenestration rings of the endograft and therefore the root cause of the balloon burst is associated with the operational context of the procedure.
Event or Problem Description
N/a.

• Brand Name: ICAST COVERED STENT SYSTEM, 5MMX22MMX120CM
• 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: 22067130
• Report Number: 3011175548-2025-000004
• Device Sequence Number: 18482414
• Product Code: PRL
• UDI-Device Identifier: 00650862425222
• UDI-Public: (01)00650862425222(17)280106
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: 42522
• Device Catalogue Number: 42522
• Device Lot Number: 516636
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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, ENDOGRAFT.
• Patient Age: 65 YR
• Patient Sex: Male