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

Model Number	85443
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Vascular surgeon stated that when the catheter delivery system had a kink in the shaft just below the balloon.Stent was deployed however it was difficult to inflate and deflate balloon due to the kink in catheter delivery system.
Additional Manufacturer Narrative
The vascular surgeon stated that the catheter delivery system had a kink in the shaft just below the balloon.Stent was deployed, however it was difficult to inflate and deflate balloon due to the kink in catheter delivery system.The device in question was not returned and no images were provided of the device.Multiple questions were asked to better understand the details of the complaint to help aid in the complaint investigation.No response from the complainant was received.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.It is a possibility that the device was damaged when the product was removed from the packaging tray prior to use and there is also a possibility that wire apposition was lost.This cannot be confirmed based on the very limited amount of information provided.Being that the shaft was kinked the device should not have been used.The instruction for use states the following: do not use the icast covered stent if the sterile package is compromised or the icast covered stent is damaged.The device history records review did not identify any non-conformances.All testing performed in regards to tensile strength of the catheter shaft passed the tensile strength requirements and multiple 100% tactile inspection for kinks at the location of the proximal balloon weld.All product quality and performance requirements were met.No related ncrs or capas were identified.The complaint history review did identify one other complaints for a kink in the shaft but was not related to this complaint.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: 12530835
• Report Number: 3011175548-2021-00998
• Device Sequence Number: 1295585
• Product Code: JCT
• UDI-Device Identifier: 00650862854435
• UDI-Public: 00650862854435
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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: 07/02/2024
• Device Model Number: 85443
• Device Catalogue Number: 85443
• Device Lot Number: 473871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 09/25/2021
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown