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

Model Number	85415
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
During a complicated aaa case while using two 7x59 stents one of the balloons only opened at the distal end.After multiple attempts to expand balloon the doctor was able to release the balloon and remove it from the partially deployed stent.
Additional Manufacturer Narrative
Based on the review of the complaint details the most likely cause for the stent only opening on one end is that the proximal end of the stent had not cleared the distal tip of the introducer sheath prior to deployment.This however cannot be confirmed without fluoroscopic images, more details from the physician or physical product in question.Based on the investigation results atrium medical corporation cannot conclude that the icast covered stent delivery system was at fault.Clinical evaluation: an abdominal aortic aneurysm is a bulging, dilation or ballooning in the wall of a blood vessel that is due to weakness or degeneration that develops in a portion of the artery wall.Just like a balloon, the aneurysm enlarges, stretching the walls of the artery thinner which compromises the artery wall's ability to stretch any further.At this point, an aneurysm is at risk of rupturing and causing potentially fatal bleeding.The best method to repair an aneurysm depends upon several factors, including the location and shape of the aneurysm as well as the physical condition of the patient.A stent will be difficult to deploy if it hasn¿t exited the sheath completely, if it has been sized incorrectly or if the lesion was not predilated.This will create a delay in treatment potentially causing further ischemia.Ischemia is a restriction in blood supply to tissues caused by thrombosis and resulting in a shortage of oxygen needed at the cellular level.The ischemia if not immediately corrected can result in tissue death or necrosis.The instructions for use (ifu) states significant amounts of air in the balloon may cause uneven expansion of the stent and difficulty in deployment of the stent.Do not pre-inflate the balloon prior to stent deployment.Use balloon-prepping technique described within this instructional material.H3 other text : not returned.

• Brand Name: STENTS I-CAST
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9752469
• Report Number: 3011175548-2020-00322
• Device Sequence Number: 2874107
• Product Code: JCT
• UDI-Device Identifier: 00650862854152
• UDI-Public: 00650862854152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 85415
• Device Catalogue Number: 85415
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1