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

Model Number	85415
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported that the surgeon implanted a stent that had expired the day before.The product was owned by the hospital.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Based on the details of the complaint a procedure was conducted utilizing a 7mm x 59mm x 120cm icast covered stent product code 85415 and after the procedure the staff realized that the icast covered stent used in the case had expired the day before.Unfortunately no lot number was provided of the icast covered stent used, therefore the manufacture date of the product in question cannot be verified.The product expiration date is clearly provided on the product label.The hospital is responsible for maintaining their inventory as this product was purchased.Once the product has been purchased atrium medical does not maintain the product inventory for the institution the product has been sold to.Because the device had expired atrium medical cannot guarantee the performance or sterilization of the product in question.The instructions for use (ifu) for the icast covered stent in the "precautions" sections states the following in regards to the product expiration: ¿the device is provided sterile, for one procedure only.Do not re-sterilize.Use prior to the expiration date noted on the package".

• Brand Name: I-CAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10440427
• Report Number: 3011175548-2020-01054
• Device Sequence Number: 3558177
• Product Code: JCT
• UDI-Device Identifier: 00650862854152
• UDI-Public: 00650862854152
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 85415
• Device Catalogue Number: 85414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 04/11/2021
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention