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

Model Number	85414
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Tech noticed stent was loose and not on the balloon, so they did not put it in the patient.
Additional Manufacturer Narrative
Analysis: a review of the returned device was conducted, upon opening the returned device it was noticed that the stent was dislodged on the balloon.The stent delivery system was very clean and showed no sign of bodily fluid.The stent was still in between the two gold radiopaque marker bands.The crimped stent diameter was measured and was 2.1mm.This diameter is indicative of a properly crimped stent.Additionally, it is clear that the stent was properly crimped as when the stent is crimped it leaves impressions of the stent frame on the surface of the balloon.The impressions are very evident.The balloon was in good condition with no signs of damage.The catheter shaft was also in good condition with no signs of damage.A full review of the catheter lot history records was performed.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).Stent retention testing.The stent must not dislodge from the balloon after crimping at a value below 5.5 newtons for a 7fr compatible device.This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.The device history records also indicate that the lowest stent retention value seen during testing was 10.5 newtons.The requirement is that the stent must not dislodge from the balloon below 5.5 newtons.The details provided indicate that the stent was loose when it was taken out of the box.The manufacturing requirement prior to packaging is to ensure that the stent is firmly crimped to the balloon.This inspection is conducted on 100% of the product produced.Based on the investigation atrium medical corporation cannot conclude that the stent was loose upon removing the device from the package.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8609573
• Report Number: 3011175548-2019-00552
• Device Sequence Number: 2169832
• Product Code: JCT
• UDI-Device Identifier: 00650862854145
• UDI-Public: 00650862854145
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/14/2019

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: 06/13/2021
• Device Model Number: 85414
• Device Catalogue Number: 85414
• Device Lot Number: 432849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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: Other