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

Model Number	85455
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The icast would not "deploy", dr.Staton was the physician.He opened a new one and it worked.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Investigation: the details provided were that the stent of the device would not deploy.The user indicated the device was being used for a vascular case (which is off-label use), also stated that the balloon did not get hung up on calcification, grafts or other stents while tracking to the intended target and the stent had cleared the introducer sheath prior to attempting deployment.The icast covered stent was returned for evaluation.The stent itself was found loose on the balloon and no longer crimped in position between the two gold radiopaque marker bands.The stent was observed to be partially off the balloon distally.The stent exhibited damage on the most distal portion of the stent.The proximal end of the stent had been flared partially.The stent was removed off the balloon.The balloon was found to still be in the folded position.The balloon did not show any signs that there had been positive pressure applied to the balloon.If there had been positive pressure applied the balloon cones of the device would have been open slightly and contrast fluid within the balloon cones.This was not observed.To ensure the balloon and stent delivery system was functional the catheter was prepped per the instructions for use and the balloon pressurized to 12atm as this is the rated burst pressure as indicated on the product label.The balloon opened fully and there were no leaks observed.The original description of the event was that the stent would not deploy.Although the stent was damaged, the undeployed stent was placed on a newly folded 7mm x 22mm catheter balloon.The stent was not crimped into position, however, when the catheter was pressurized to the nominal inflation pressure of 8atm as indicated on the product label, the stent opened without issue.Based on the initial investigation of the returned product the complaint cannot be confirmed.The stent was able to be deployed and the stent delivery system functioned properly and within specifications.The position of the stent on balloon as received was out of specification as it was not within the radiopaque markers and was not crimped.However, based on the condition of the returned device it is likely the stent was damaged while either being advanced to the intended target or while withdrawing back through the introducer sheath (or both).The introducer sheath type and size was not provided by the user.The device history records review did not identify any non-conformances.All product quality and performance requirements were met.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.

• 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: 16505352
• Report Number: 3011175548-2023-00073
• Device Sequence Number: 19671458
• Product Code: JCT
• UDI-Device Identifier: 00650862854558
• UDI-Public: 00650862854558
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 11/21/2025
• Device Model Number: 85455
• Device Catalogue Number: 85455
• Device Lot Number: 491599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female