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

Catalog Number 85414

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 07/17/2019

Event Type  Injury  

Event Description

The patient was having a tavr procedure in the cath lab.Due to a high stick, there was bleeding in the left femoral artery and in order to repair, the physician attempted to place 2 stents in the lfa/iliac.One stent was deployed and the other slipped off of the balloon, going into the body not inflated.Patient had to have an open arteriotomy of the vessel to retrieve the undeployed stent and to repair the vessel.

• Brand Name: ICAST
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental boulevard; merrimack NH 03054
• MDR Report Key: 8939756
• MDR Text Key: 155816472
• Report Number: 8939756
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/12/2019,07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 85414
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29200 DA