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

Model Number	85455
Medical Device Problem Codes	Fracture (1260); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
During the procedure the stent broke while being deployed, a new device was used to complete the procedure.No injury or harm to the patient.
Additional Manufacturer Narrative
Additional information: section d9 & h6.Investigation summary: the claim was that "the stent broke while being deployed".This product was being used when the incident occurred.All pieces of the fractured stent were immediately recovered and accounted for.There was no break in the operative procedure.The patient sustained no injury and the procedure continued.Multiple questions were asked to obtain more specific details about the complaint.The answer to the question ¿please explain how the stent broke while being deployed? (e.G.Dislodged during stent delivery, balloon burst/rupture during deployment?).The answer provided was ¿dislodged during delivery¿ but did not elaborate further.It is not known at what point during delivery this occurred.Its possible the stent dislodged in the sheath or possibly after passing through the sheath or upon withdrawal back into the sheath.The answers received provided no insight as to how the stent dislodged.Most questions were not answered as the response stated were mostly that ¿answer not provided due to the surgeon not being available to question¿.The returned device was evaluated.Upon opening the returned device it was clear the stent was no longer on the balloon, indicating that "stent broke while being deployed" referred to a stent dislodgement.This complaint is considered confirmed.It is not clear from the evaluation or information provided when or how the dislodgement occurred.The balloon was in good condition and still in the folded position.There were no signs of positive pressure and there were no signs of fluid in the balloon.The stent when properly crimped on to the balloon leaves impressions of the stent frame on the balloon surface.Theses crimp marks on the balloon were very clear and are indicative of a properly crimped stent.The introducer sheath used in the case was not provided.There is no indication that the device was provided nonconforming.Based on the damage of the stent it is possible that the patient¿s anatomy was tortuous making passage through the sheath difficult.As the actual procedural details were not provided there is a possibility the target lesion was also at an acute angle.In this regard it is also possible that the sheath deformed or even kinked during the procedure making passage of the stent delivery system extremely difficult.A definitive root cause cannot be determined based on the device evaluation.The review of the device history records related to this product lot was conducted and there were no ncr's or non-conformances related to the complaint and the stent retention force exceeded the dislodgement force requirements.In review of similar complaints, the stents had dislodged either within the introducer sheath or after placing through the entire length of the introducer sheath.None of the closed complaints were confirmed to be the fault of the device and all were assigned a root cause of impossible to define.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: 19489965
• Report Number: 3011175548-2024-00132
• Device Sequence Number: 20605360
• Product Code: JCT
• UDI-Device Identifier: 00650862854558
• UDI-Public: 00650862854558
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/29/2024

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: 10/02/2026
• Device Model Number: 85455
• Device Catalogue Number: 85455
• Device Lot Number: 501904
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown