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

Model Number 85415

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Report received stated that after implantation of an icast stent, the customer found that they had implanted an expired product.

Event Description

N/a.

Manufacturer Narrative

Based on the details of the complaint the physician implanted an icast covered stent that had expired.The product label that is adhered to the box and also on the product pouch inside the box clearly shows the product expiration date.The device history record review confirmed that the product expiration date was 21-dec-2020.A review of the product labeling specification in regards to the product expiration date of three years was conducted.The product label specification document ls009046 label, printed icast low profile was created in 2012 and at this time the expiration date was three years and has remained unchanged.A review of the quality inspection procedure qp001705 pre-sterilization inspection of endovascular and related catheters also requires that the quality inspector verify the expiration date on the representative label attached to the device history record.The dhr shows that the product was packaged and labeled 21-dec-2017 and corresponds with the product expiration date of three years as the expiration date of the product is 21-dec-2020.Hospital guidelines require close monitoring of the products that are held in stock to prevent aging products from remaining on the shelf.A second mechanism is at the procedure table prior to entry onto the sterile field when the expiration date should be confirmed and recorded.In the case where an expiration date has passed and the product is used there would be no guarantee of sterility of that product.Failure to diligently monitor available stock puts the patient population at risk.This represents a failure of the system established within the institution to guarantee safe practice in the delivery of health care.The instructions for use (ifu) clearly state in the precautions section the following: ¿the device is provided sterile, for one procedure only.Do not re-sterilize.Use prior to the expiration date noted on the package".The complaint has been confirmed through a review of the labeling.The complaint details report that the device was implanted on (b)(6) 2021, and that the expiration date of the device was 21-dec-2020.Based on a review of the device history record and labeling for the affected lot: 425809, the device is confirmed to have been labeled to expire on this date, which is prior to use by the facility.There is no other allegation of a device nonconformance.H3 other text: device not available for return.

Event Description

N/a.

• Brand Name: STENTS I-CAST
• Type of Device: 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: 11283236
• MDR Text Key: 230436587
• Report Number: 3011175548-2021-00123
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854152
• UDI-Public: 00650862854152
• Combination Product (y/n): N
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2020
• Device Model Number: 85415
• Device Catalogue Number: 85415
• Device Lot Number: 425809
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/25/2021; 05/06/2022
• Supplement Dates FDA Received: 02/27/2021; 05/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 94 KG