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

Model Number	85450
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
Hospital surgeon states: icast stent fell off prior to deployment.
Additional Manufacturer Narrative
Additional information: section b5 & d10.
Event or Problem Description
Hospital surgeon states: icast stent fell off prior to deployment.They decided they needed a smaller size and during the removal of the stent in the tourguide sheath, the stent separated from the balloon at the valve of the sheath.The sheath was then removed with the stent inside and the case continued with no complications.
Additional Manufacturer Narrative
Additional information: section d9 & h6 based on the details of the complaint the icast covered stent was to be used in a physician modified endograft procedure with the intent to place the stent in the celiac artery.The details mention that upon delivering the stent through the medtronic tourguide® steerable introducer sheath the physician decided a smaller size was needed and during the removal of the catheter back through the introducer sheath the crimped stent came off the balloon at the location of the septal valve within the introducer sheath.The sheath was then removed with the stent inside and the case continued with no complications.The device in question was not returned and no images were provided of the device in question.The complaint is confirmed because it occurred due to user error, however without the device in question or images of the device, a nonconformance with the device cannot be confirmed.A review of the device history records show there were no non conformances noted during the manufacture of this lot of catheters and the performance testing of this lot of catheters passed all requirements.A complaint history review identified similar complaints where the physician attempted to pull an unexpanded stent back into the sheath and the stent dislodged from the catheter.No complaints confirmed a nonconformance with the device and the root cause was operator error.The labeling review determined that the instructions for use provided with the icast covered stent provides clear warnings and precautions related to vascular usage, as well as clear precaution and instruction against pulling an unexpanded stent back through the introduction device, noting this can lead to stent dislodgement.As such, the guidance for removal of an unexpanded stent was not followed by the user in this case.Based on the review of the details provided where the stent was pulled back thorough the introducer sheath against the instructions for use and review of the device history records where no anomalies were noted during the manufacture of this lot of catheters, there is no evidence to conclude the device was at fault.As the device chosen by the physician was not of the proper size and was pulled back through the sheath against the instructions for use the root cause is user error.Based on the findings of this investigation, including the identified root cause, risk review, and trend review, no escalation or corrective actions are needed.There is currently an active capa (768554) associated with updating risk documentation for the failure mode associated with the withdrawal of undeployed stents and dislodgements of the stents when pulling the stents back through the introducer sheath.This active capa addresses the needed risk updates to ensure that the hazardous situation of stent dislodgement is adequately associated with the failure mode of attempting to withdraw an undeployed stent through a guiding catheter or sheath.Additional escalation of this complaint is not required.H3 other text : device not available for return.
Event or Problem Description
N/a.

• Brand Name: STENTS I-CAST
• 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: 18595546
• Report Number: 3011175548-2024-00013
• Device Sequence Number: 6811056
• Product Code: JCT
• UDI-Device Identifier: 00650862854503
• UDI-Public: 00650862854503
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2025
• Device Model Number: 85450
• Device Catalogue Number: 85450
• Device Lot Number: 485172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 01/29/2024; 03/13/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 01/29/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2022
• 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: TOURGUIDE SHEATH
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 695 KG