MAUDE Adverse Event Report: ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	85452
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/20/2019
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
During the endovascular repair of an aortic aneurysm within the interventional radiology department of our institution, an expired stent was inserted into a patient¿s renal artery.Following the deployment of the stent it was noticed that the expiration date was 05/17/19.
Additional Manufacturer Narrative
Analysis: all icast covered stent delivery systems are manufactured with a 3 year shelf life at the time of manufacturing.The product, once sold to the institution and entered into their inventory, is no longer tracked by atrium to ensure the device does not expire.The inventory and expiration dates are the sole responsibility of the institution.It was reported that after the stent was provided from the hospital inventory and deployed in the patient¿s renal artery, the device in question was discovered to have expired.The nurse made the discovery during her post procedure documentation, after implantation of the icast.It was also noticed, after the procedure, that there were two other icast covered stent delivery systems in the hospital inventory that had also expired.It is the expectation that the staff of the hospital maintains the inventory to ensure the product being presented to the physician is in good condition and not expired.This step was not conducted prior to the implantation of the icast covered stent.A review of the device history records indicates that this lot of catheters passed all quality and performance requirements.Conclusion: based on the results of the investigation the hospital did not follow standard practices of inventory control or product verification prior to use in regards to verification of expiration dates.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• MDR Report Key: 8753899
• Report Number: 3011175548-2019-00734
• Device Sequence Number: 2155244
• Product Code: JCT
• UDI-Device Identifier: 00650862854527
• UDI-Public: 00650862854527
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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 Expiration Date: 05/17/2019
• Device Model Number: 85452
• Device Catalogue Number: 85452
• Device Lot Number: 238596
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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: Other