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

Model Number	85404
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Stent has snapped off within the sheath, entire sheath was removed and upon inspection saw that balloon snapped off the shaft patient was not harmed.
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: this complaint reports that the balloon of an icast stent (p/n 85404) broke off within the introducer sheath as it was being withdrawn.As the delivery system was being withdrawn it encountered resistance and then the balloon separated from the rest of the catheter.The entire introducer sheath was removed, along with the catheter and separated balloon.The hospital reported that the stent was successfully placed before the incident and that there was no additional harm to the patient as a result.The lot number was not provided.No pictures were provided.The device was disposed of by the customer and will not be returned for evaluation.Additional information was requested from the hospital but none has been received.The hospital informed atrium that they would like to retract the complaint since the stent was successfully placed.The sales history of this customer showed that they have not received p/n 85404 from atrium, and so not possible lot numbers could be identified.Because the lot number and manufacturing date is not known, contemporaneous devices cannot be evaluated.No additional information was provided about surgical technique and the model and size of the introducer sheath is not known.What is known is that the clinician experienced resistance while trying to withdraw the delivery system after placing the stent and continued withdrawing until the balloon separated from the catheter.Known causes of this type of component separation are failure to fully deflate the balloon and using a smaller than recommended introducer sheath.Either of these can lead to the delivery system encountering resistance while being withdrawn, as occurred in this case, and result in component separation.Without more information there is no way to know the exact cause of this complaint.A dhr review could not be completed because the lot number was not provided.Relevant manufacturing procedures and part specifications were reviewed and no evidence was identified to suggest that manufacturing, materials, equipment, or design are related to this complaint.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No trending excursions were identified.The ifu warns the user not to force passage or withdrawal of the delivery system if resistance is encountered.It also cautions the user not to attempt withdrawal of the delivery system if the balloon is not completely deflated.No evidence of the event was provided and the device has not been returned.Additionally, atrium has no record of shipping p/n 85404 to this customer in the 3 years prior to this complaint.Neither the complaint nor a device nonconformity can be confirmed.The root-cause of this complaint is user error.No evidence was identified to suggest that this complaint is related to design, manufacturing or instructions for use.Information provided by the customer indicates that they attempted to withdraw the stent delivery system through the sheath despite encountering resistance, which is warned against in the ifu.H3 other text : device not available for return.

• 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: 17895511
• Report Number: 3011175548-2023-00189
• Device Sequence Number: 17887430
• Product Code: JCT
• UDI-Device Identifier: 00650862854046
• UDI-Public: 00650862854046
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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 Model Number: 85404
• Device Catalogue Number: 85404
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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