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

Device Problem Material Rupture (1546)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/10/2021

Event Type  malfunction  

Event Description

Balloon stent icast 10 mm x 38 mm x 80 cm ruptured when dr implanted it on the left iliac.Balloon stent inspected by surgeon by inflating and making sure everything is intact.Surgeon informed staff and charge nurse that balloon stent is intact.The surgeon identified occlusion at left lower artery and at the anterior tibial artery.

• Brand Name: ICAST
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 11706140
• MDR Text Key: 246686763
• Report Number: 11706140
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 55