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

Model Number 85445

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

Md was expanding the covered balloon expanding stent in the superior mesenteric artery (sma).When removing the stent catheter, the balloon broke off inside the sheath that was inside the patient.Md was able to retrieve the broken piece and all pieces were accounted for.

• Brand Name: ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 14999818
• MDR Text Key: 295782537
• Report Number: 14999818
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85445
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Female
• Patient Weight: 88 KG