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

Model Number	85455
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hospital states, "we did a case with dr.Kimball on tuesday and the stent fell of the wire as they were putting it in the patient".There was no harm to the patient and another stent was used for the procedure.
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
Based on the details of the complaint "the stent fell off the wire as they were putting it in the patient.There was no harm to the patient, they were able to use another stent and make it work".Multiple questions were asked to clarify the incident.Based on the response, the stent was dislodged off the balloon as the device was attempted to be withdrawn back through the introducer sheath.The icast was withdrawn as the physician required a longer length device.The procedure was a physician built four vessel endovascular aneurysm repair procedure and the icast was intended to be deployed in the renal artery through an ascor introducer sheath.The icast covered stent has not been tested and or evaluated for use in conjunction with an endograft for the purpose of aneurismal repair.The device in question was returned and evaluated to determine the cause of the complaint.Upon opening the returned device, it was clear that the stent had been shifted distally off the balloon.The stent was in good condition and was still partially on the balloon.The stent was removed, and the surface of the balloon inspected.During the process of manufacturing the stent is crimped on to the balloon.This process leaves very defined impressions of the stent frame on to the underlying balloon.This returned device had very defined impressions of the stent frame on the balloon surface indicating that the stent was fully crimped into position.There was however blood noted to be inside the folded balloon.For blood to be within the balloon there would have to be a leak in the catheter.Upon further inspection a small puncture hole was noted on the balloon surface over the distal radiopaque marker band.The hole in the balloon was large enough that it is likely the balloon would not have been able to hold pressure.Based on the details provided and the fact that the icast was used in conjunction with a fenestrated endograft it is very likely that the balloon was ruptured on one of the fixation barbs of the endograft.Being that this was a physician modified endograft procedure there is also a possibility that the balloon ruptured on the fenestration ring that was created by the physician.Furthermore, the hole in the balloon is not consistent with any balloon pin holes or defects seen in the past in regards to the manufacturing process.A review of the device history records associated with the manufacture of the product shows that the product was manufactured properly and that there were no non-conformances during the manufacture of the product in regards to the balloon and balloon performance, nor the stent retention.Performance testing, as documented in the dhr, shows that the testing related to advancement of the crimped stent through the labeled introducer sheath and stent deployment without stent movement or stent deployment issues all passed, and that the minimum stent retention value observed in the lot exceeded the minimum performance requirement.The labeling review and complaint investigation determined that the device in this case was used off-label in a vascular procedure, in conjunction with an introducer sheath and a fenestrated endograft.Regardless, the ifu provides clear indication that pulling an unexpanded stent back through the introduction device poses a risk of stent dislodgement.As the icast covered stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms and not within the vasculature there is no warnings or cautions in regard to use with adjunct devices such as an endograft as described in this complaint.Based on the details of the event the stent was dislodged while attempting to pull the stent back through the introducer sheath against the instructions for use.Therefore, the root cause of the complaint is user error and operational context.In regard to the hole found in the balloon there is no evidence that the product was shipped with a hole in it and was likely punctured on the fixation barb of the endograft; also considered user error and operational context of the procedure.A historical review and risk review did identify that there have been similar complaints where the stent dislodged during withdrawal back through the introducer sheath.A capa request has been initiated due to an identified occurrence level excursion for the month of (b)(6) 2022, in which the actual occurrence rate exceeded the anticipated occurrence rate as a result of two complaints, inclusive of this one.
Event or Problem Description
N/a.

• 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: 15614635
• Report Number: 3011175548-2022-00298
• Device Sequence Number: 7970389
• Product Code: JCT
• UDI-Device Identifier: 00650862854558
• UDI-Public: 00650862854558
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2023

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: 04/12/2025
• Device Model Number: 85455
• Device Catalogue Number: 85455
• Device Lot Number: 483280
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 01/20/2023
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/08/2022; 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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: OSCOR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male