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

Model Number	85416
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a z-fen case the doctor tried to track the icast stent into the celiac artery when the stent detached prematurely from the balloon.The doctor then removed the catheter and the sheath with the stent in the sheath.The doctor then tried the same procedure again with a new icast stent and the same situation occurred again.The doctor then used a 7x38x120 icast stent that was successful.The patient did not have any complications.
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Additional Manufacturer Narrative
Additional information: e1 and e3.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Based on the details and the correspondence the stents had dislodged inside the cook introducer sheaths while advancing through the described tortuous iliac artery during a fenestrated endograft procedure with the intended target being the celiac artery.The devices in question were not returned and no images of the devices in question were received.Being that this event occurred twice with one clinical procedure suggests that the sheath was in a very tight bend that may have contributed to the stent dislodgement.As the details provide a 7mm x 38mm icast was able to pass supports this suggestion.A review of the device history records going back to the stent sub assembly level shows that there were no non-conformances noted and the product met all quality and performance requirements.This includes a review of the stent crimping process as well as the advancement of the crimped stent through the labeled introducer sheath without sheath compatibility issues.A labeling review was conducted.The ifu was found to provide adequate instructions in regards to the proper handling and delivery of the stent and not to force passage or removal of the stent if resistance is met.A risk review found that the risk management documents for this product adequately address the reported defect and the severity.As the anticipated occurrence level has been exceeded there has been a corrective action request generated.Based on the information provided in the complaint and within the investigation performed, there is no evidence to conclude that the devices were faulty or manufactured improperly.Without the actual devices used in the case, images or the introducer sheaths the complaint cannot be confirmed.Based on the investigation the root cause is impossible to define.Based on the review, the product met all quality and performance requirements at the time of manufacture.

• 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: 15228052
• Report Number: 3011175548-2022-00236
• Device Sequence Number: 5566661
• Product Code: JCT
• UDI-Device Identifier: 00650862854169
• UDI-Public: 00650862854169
• 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): 12/15/2022

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 Expiration Date: 03/28/2025
• Device Model Number: 85416
• Device Catalogue Number: 85416
• Device Lot Number: 482757
• 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: 08/02/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 12/13/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 08/16/2022; 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2022
• 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: COOK ZENITH MD MODIFIED ENDOGRAFT
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 86 KG