MAUDE Adverse Event Report: ATRIUM MEDICAL ICAST COVERED STENT; PROSTHESIS, TRACHEAL

Model Number	85416
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2018
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
It was reported that during an fenestrated endovascular aneurysm repair the surgeon placed the icast stent into the sheath and then pulled i out.When they pulled it out of the sheath, the stent fell off the balloon.The procedure was completed with a different device.
Additional Manufacturer Narrative
Analysis: based on the details of the complaint the stent was dislodged when the stent was introduced and for some reason removed back through the sheath.Questions were asked of the institution as to why the stent and catheter were removed back through the introducer sheath.It was not clear as to why this pre-mature withdrawal of the catheter was performed.The instructions for use specify the following in regards to removing an unexpanded stent back through the sheath: ¿do not withdraw the icast covered stent back into the bronchoscope or endotracheal tube once the device is fully introduced.¿ in some instances when the stent is advanced through the introducer sheath and the stent withdrawn back through the sheath, the proximal end of the crimped stent can make contact with the distal tip of the introducer sheath dislodging the stent or losing the stent off the balloon all together.As the device was not returned a thorough investigation could not be performed.The introducer sheath used in the case was not returned.As the lot number of the device was not provided an evaluation of the production lot history records could not be performed including the performance testing results of the product.If the lot number had been provided an evaluation of the following would have been conducted: 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 (7fr).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).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.Distal tip tensile testing.Catheter leak check.Atrium medical only release production lots that have passed the aforementioned performance and quality requirements.Conclusion: based on the details provided there is not enough evidence to conclude that the stent dislodgement was related to a design or manufacturing error.Based on the complaint details the stent may have dislodged while withdrawing back through the sheath.Atrium medical has not tested or evaluated the use of the icast covered stents in conjunction with fenestrated endovascular aneurysm repair.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7802648
• Report Number: 3011175548-2018-00908
• Device Sequence Number: 19310117
• Product Code: JCT
• UDI-Device Identifier: 00650862854169
• UDI-Public: 00650862854169
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 85416
• Device Catalogue Number: 85416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention