MAUDE Adverse Event Report: MAQUET MEDICAL ATRIUM/MAQUET; ICAST COVERED STENT

Model Number ICAST 6MM X 22M X 80 CM

Device Problems Positioning Failure (1158); Separation Failure (2547); Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 01/26/2016

Event Type  Injury  

Event Description

The stent failed to deploy fully as the balloon was ruptured.The distal edge of the stent expanded, but the proximal remained crimped on the balloon.The stent could not be shaved off the balloon and had to be surgically removed.

• Brand Name: ATRIUM/MAQUET
• Type of Device: ICAST COVERED STENT
• Manufacturer (Section D): MAQUET MEDICAL ; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 5535734
• MDR Text Key: 41554145
• Report Number: 5535734
• Device Sequence Number: 1
• Product Code: JCT
• 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: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2018
• Device Model Number: ICAST 6MM X 22M X 80 CM
• Device Catalogue Number: 85443
• Device Lot Number: 231166005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/26/2016
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 94