MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 7MMX22MMX120CM; ILIAC COVERED STENT, ARTERIAL

Model Number	42722
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, icast stent was dislodged from the balloon as it was inserted through the hub assembly.The sheath and balloon was removed over the wire as one unit.No adverse event was reported.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Additional information section: a2, d9, e1, h6.The details state the following: "during a fenestrated case an icast was being inserted thru an aptus tourguide, (b)(6).The stent became dislodged from the balloon as it was inserted thru the hub assembly.The sheath and balloon were removed over the wire as one unit.Dr ali rana was the vascular surgeon.No unintended section of this device remained inside the patient¿s body.The patient was not hospitalized and did not undergo prolonged hospitalization due to this occurrence.The patient did not experience a delay or require any additional procedure due to this occurrence.The complainant did not report any adverse effects on the patient due to this occurrence." the device in question was received and evaluated to determine the cause of the complaint.Upon review the stent was no longer on the catheter and the balloon of the catheter had impressions of the stent frame on its surface.These impression of the stent frame on the balloon surface are indicative of a stent that was properly crimped in manufacturing.The stent was not located within the introducer sheath nor was it located within the packaging materials.The aptus tourguide sheath used in the case was also returned, upon inspection the sheath size was a 6.5fr sheath.This is important as the icast covered stent used in the case requires a 7fr introducer sheath as indicated on the product label that is located on both the product box and inner pouch containing the product.As the sheath was undersized, this is the cause that the stent would not fit through the sheath.Based on the review of this device history record, all stents were passed through the 7fr introducer sheath without issue, deployed properly, and the balloons fully deflated and withdrawn back through the introducer sheath without incident indicating the devices were manufactured properly.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 3.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.The complaint history and capa searches did not identify any related complaints for incompatible accessory used during procedure/additional intervention required in the time period reviewed.Based on the investigation it was determined the root cause to be that the wrong size introducer sheath was used and therefore the root cause is user error.As the device returned did have the stent no longer on the balloon the complaint is considered confirmed however based on the investigation results there is no evidence to conclude the stent dislodgment was due to the manufacturer.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: e1 (event site email, event site telephone).

• Brand Name: ICAST COVERED STENT SYSTEM, 7MMX22MMX120CM
• 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: 21164673
• Report Number: 3011175548-2025-000000
• Device Sequence Number: 4273544
• Product Code: PRL
• UDI-Device Identifier: 00650862427226
• UDI-Public: (01)00650862427226(17)270110
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2025

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: 42722
• Device Catalogue Number: 42722
• Device Lot Number: 505105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 02/10/2025; 03/01/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/18/2025; 03/05/2025
• 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: APTUS TOURGUIDE, 7FRX17MMX55CM
• Patient Age: 64 YR
• Patient Sex: Male