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

Model Number	85418
Medical Device Problem Codes	Premature Activation (1484); Premature Separation (4045)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
Report received from fda¿s medwatch program (mw5104099).Report stated that the patient was having surgery for endovascular thoracoabdominal aortic aneurysm repair when the stent prematurely separated from the delivery system.Surgeon was able to retrieve undeployed stent completely.
Additional Manufacturer Narrative
Additional information: section d4, h4, h6 - we identified the lot number, based on the expiration date and product code provided in the medwatch.Corrected information: section h6 - health effect - impact code.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A report was received from fda¿s medwatch program (mw5104099).Report stated that "patient was having surgery for endovascular thoracoabdominal aortic aneurysm repair when the stent prematurely separated from the delivery system.Surgeon was able to retrieve undeployed stent completely.".No contact information for the reporter was provided; therefore, no additional information was able to be obtained.No product has been returned, nor images provided.As noted in the dhr review section, the lot number was deduced based on the product code provided and expiration date.An attempt was made to obtain companion samples from the affected lot of icast devices, and companion lot of advanta v12 devices manufactured from the same crimped top assembly lot.No devices remained in inventory for evaluation.There were no other lots of the same product code manufactured in the immediate timeframe from which to pull contemporaneous samples.Therefore, no device evaluation can be performed for this investigation.Based on the very limited details available, the complaint cannot be confirmed and root cause cannot be determined.The device history records review did not identify any non-conformances.All testing performed in regards to stent retention and sheath passage without stent dislodgement passed.All product quality and performance requirements were met.There was no on demand maintenance of associated manufacturing or test equipment identified around the time of manufacture and all equipment was in calibration.No significant design, material, procedural or process changes around the time of device manufacture have been identified.No related ncrs or capas were identified.The complaint history review did identify other complaints for stent dislodgement; however, it is not known if they are related to this complaint, as the details of the procedure, including at what point of the procedure the stent dislodged, are unknown.The labeling review determined that the icast device was used off-label in a vascular procedure.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.H3 other text : device not returned.

• 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: 12579440
• Report Number: 3011175548-2021-01019
• Device Sequence Number: 15101972
• Product Code: JCT
• UDI-Device Identifier: 00650862854183
• UDI-Public: 00650862854183
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2023

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: 06/01/2023
• Device Model Number: 85418
• Device Catalogue Number: 85418
• Device Lot Number: 460724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 12/20/2022; 01/27/2023
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 01/10/2023; 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown