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

Model Number	85453
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.Not available for return.
Event or Problem Description
As part of the (b)(6) study being conducted by cook, inc., the following event was noted: 37 days fenestrated endovascular aneurysm repair, additional stent placement was performed to treat a type ic distal endoleak at the right renal stent.Treatment included extending the right renal stent with an additional stent.
Additional Manufacturer Narrative
Analysis: a review of the complaint details was conducted to determine the cause of the type ic endoleak.Based on the details, the stent that was placed within the fenestration ring of the zenith p-branch graft and the right renal artery and after 37 days of the initial implantation of the icast covered stent the endoleak was noticed.The details mention that the end of the stent was flared at the ostium of the endograft.It is unknown based on the details exactly where the endoleak was generated from.Being that the stent was placed through a fenestration ring of an endograft it is presumably at the location.The junction between the endograft and the fenestration ring of the endograft as it enters the right renal artery.Based on the details provided it would appear that an adequate seal was not achieved between the icast covered stent and the endograft fenestration ring during the flaring process.The endoleak was not caused by the icast covered stent but rather an inadequate seal between the endograft and the covered stent.The flaring of the stent is dependent of the technique chosen by the physician.A full review of the catheter lot history records was performed.Below is an overview of the quality and performance criteria that every lot of icast covered stent systems is tested to.This inspection requires that the catheter lot must pass the following: ¿ ability of the stent and delivery system to be passed through the labeled introducer sheath (6fr).¿ ability to deploy the stent at nominal pressure (8atm).¿ ability to withdraw the deflated balloon catheter back through the labeled introducer sheath ¿ ability of the delivery system to withstand 5 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.¿ balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm) ¿ stent retention testing.Stent must have retention = 5.5n for 6fr introducer sheath/guide.In addition to the final lot qualification testing there are multiple in-process inspections conducted that include the following: ¿ balloon hole skive dimensional verification.¿ stent securement testing.¿ proximal balloon weld tensile testing as detailed above.¿ distal tip tensile testing.¿ catheter leak check this lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.Atrium medical only releases production lots that have passed the aforementioned performance and quality requirements.Conclusion: based on the review of the complaint details and the device history records review atrium medical cannot conclude that there was an issue with the product in question.The seal between the icast covered stent and the endograft fenestration ring during the flaring process is dependent of the technique chosen by the physician.
Event or Problem Description
N/a.

• Brand Name: I-CAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8900026
• Report Number: 3011175548-2019-00867
• Device Sequence Number: 18892750
• Product Code: JCT
• UDI-Device Identifier: 00650862854534
• UDI-Public: 00650862854534
• Combination Product (Y/N): N
• Initial Reporter State: MA
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2021
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 431777
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PBRANCH-36-22-AA UNIBODY-24-81
• Outcome Attributed to Adverse Event: Required Intervention