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

Model Number	85414
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation a follow up report will be submitted.
Event or Problem Description
Report received stated that a physician implanted an icast stent in a patient that the stents expiration date had expired.The stent was implanted in the subclavian and the patient is reported to be in stable condition.
Additional Manufacturer Narrative
Analysis: the details of the complaint provided by the institution state that the product had been implanted after the product had expired.The lot number of the device was not provided.The label on the front of the box and the front of the packed pouch within the box both have the expiration date and lot number provided.Without the product lot number a review of the device history records cannot be conducted including the sterility records.Atrium medical corporation only releases product that has met all quality and performance requirements.The product once purchased by the institution is no longer tracked by atrium medical corporation.The handling and storage of the product is the responsibility of the institution.Atrium medical corporation cannot guarantee the performance or the sterility after the product has expired.The hospital did not report the lot number but did report the expiration date.Ln this case the product had expired on 29 jan 2020.The procedure conducted that used the expired icast covered stent was performed on (b)(6) 2020.Summary/conclusion: based on the review of the complaint details the product was used after the expiration date and is considered user error.The instructions for use clearly state the following: ifu aw010835 rev aa.¿precaution # 7.The device is provided sterile, for one procedure only.Do not re-sterilize.Use prior to the expiration date noted on the package h3 other text : product not available for return.

• 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: 9744028
• Report Number: 3011175548-2020-00313
• Device Sequence Number: 14067464
• Product Code: JCT
• UDI-Device Identifier: 00650862854145
• UDI-Public: 00650862854145
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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 Expiration Date: 01/29/2020
• Device Model Number: 85414
• Device Catalogue Number: 85414
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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