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

Device Problems Detachment Of Device Component (1104); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2016

Event Type  malfunction  

Event Description

Stent came off the balloon and was stuck inside the sheath.Sheath removed with stent inside the sheath.The patient was not harmed.

• Brand Name: ICAST
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth dr.; hudson NH 03051
• MDR Report Key: 5623614
• MDR Text Key: 44139419
• Report Number: 5623614
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2016,04/07/2016

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 74