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

Model Number	85424
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported that during deployment of the stent, the balloon got caught on the stent and remained in the dog-bone position.The surgeon was unable to deploy the stent.It was removed and a different product was used.
Additional Manufacturer Narrative
Additional information: section d.10.
Additional Manufacturer Narrative
Upon inspection of the returned balloon catheter, the balloon was in good condition and showed no signs of damage.The catheter shaft was in good condition and there were no signs of kinking that would have prohibited the flow of fluid to the balloon.To ensure the integrity of the balloon, the balloon was inflated to 8atm and 12atms of pressure as this is the nominal and rated burst pressure of the balloon as indicated on the product label.The balloon did not show any evidence of leaking.The inflation skive holes under the balloon that inflate the balloon from both ends (creating the "dog bone") affect were both patent as fluid was seen entering the balloon at both locations under the microscope and the balloon exhibited the appropriate shape.The actual stent was not returned.The details mention that the stent was left in place and an additional 10x 38 stent was placed.No images of the device in place or under fluoroscopy were provided.The second device used was reported to be successfully deployed.Based on the evaluation of the returned balloon catheter it is unknown why the first stent did not deploy successfully considering that the balloon catheter functioned appropriately when tested.Being that the second stent could be deployed suggests that the first stent could be expanded.A review of the device history records indicate that this lot of icast covered stent delivery systems passed all quality and performance requirements.This includes the expansion of 20 stents on balloon catheters as part of the part qualification testing that is conducted following quality procedure.All 20 samples passed without issues in regards to proper stent deployment.Based on the details of the complaint and the appropriate functionality of the returned product the reported complaint cannot be confirmed.

• 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: 10431828
• Report Number: 3011175548-2020-01052
• Device Sequence Number: 3569265
• Product Code: JCT
• UDI-Device Identifier: 00650862854244
• UDI-Public: 00650862854244
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2020

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 Expiration Date: 04/02/2023
• Device Model Number: 85424
• Device Catalogue Number: 85424
• Device Lot Number: 458225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/15/2020; 02/01/2021
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/25/2020; 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 72