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

Model Number	85416
Medical Device Problem Codes	Material Rupture (1546); Separation Failure (2547)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Balloon ruptured and broke off the catheter while attempting to remove the device.The wire was advanced to the contralateral side and exited through pre-existing sheath.A dilator was used to push the ruptured balloon over the wire into the sheath on the other side.The balloon was unsuccessfully pushed into the sheath.The sheath was removed with the balloon hanging out.Stent was successfully implanted and patient was unharmed.
Additional Manufacturer Narrative
Additional information: d10.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The following details were provided regarding this product complaint, "balloon ruptured and the broke off the catheter while attempting to remove the device.The wire was advanced to the contralateral side and exited through pre-existing sheath.A dilator was used to push the ruptured balloon over the wire into the sheath on the other side.The balloon was unsuccessfully pushed into the sheath.The sheath was removed with the balloon hanging out.Stent was successfully implanted and patient was unharmed".The lot number of the product received was not provided therefore a review of the device history records could not be performed.A review of the physical product was conducted.Upon initial inspection, the balloon had been separated from the catheter shaft at the location of the proximal balloon weld, confirming the alleged component separation.The balloon had been inverted backward distally down the catheter shaft.The proximal balloon weld was still intact.Functional testing of the device was performed.The balloon was not leaking, as initially indicated in the complaint details, and the inflation skives beneath both the balloon and manifold, as well as the catheter shaft lumens were found to be patent.Therefore, there is no evidence of a manufacturing defect or evidence that the product did not meet specifications.Based on the details of the complaint, the product size involved, and investigation conducted, it is likely that this complaint is of the same root cause as that identified in ongoing capa 429004, such that it is likely that the balloon was not allowed sufficient time to deflate prior to withdrawal of the balloon and/or was not visualized to be fully deflated under fluoroscopy.When there is fluid still remaining in the balloon, when the catheter is pulled back into the sheath the fluid gets pushed to the distal end of the balloon creating a plug at the end of the sheath.If too much force is applied the shaft will stretch and break near the proximal balloon weld and/or the manifold hub.It is for this reason that the most probable root cause is operational context.A secondary root cause is design, based on the findings of capa 429004, as with the use of contrast, the balloon deflation time can take longer than the 40s as specified in the ifu (based on the use of water) for larger size balloons.The icast device in this complaint was used in an off-label kissing iliac stenting procedure.The icast device is currently indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.Per hhe2021007, the current icast ifu was found to provide sufficient instruction to the user for balloon deflation and withdrawal for the intended indication (tracheobronchial), but does not provide instruction for use in the off-label vascular applications where contrast is used, as these indications are not currently approved by the fda.This discrepancy in labeling with regards to use of the device in vascular applications is being addressed by capa 429004, hhe 2021007 (associated with icast tracheobronchial use)/hhe2021005 (associated with vascular use), and the associated field action (recall number z-1077-2022).Capa 429004 is currently in the implementation phase.

• Brand Name: I-CAST COVERED STENT
• 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: 11998321
• Report Number: 3011175548-2021-00665
• Device Sequence Number: 17000597
• Product Code: JCT
• UDI-Device Identifier: 00650862854169
• UDI-Public: 00650862854169
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 85416
• Device Catalogue Number: 85416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/22/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 07/20/2022
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/21/2021; 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1077-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown