MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM I-CAST COVERED STENT

Model Number 85453

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2014

Event Type  Injury  

Event Description

The case was for a fenestrated abdominal aortic aneurysm.While attempting to advance the second of three i-cast stents through a 6fr flexorsheath introducer sheath resistance was met.The stent came off the system while inside the sheath hub.The third stent was deployed successfully with no issues.The introducer sheath required readjustment but was not replaced.

Manufacturer Narrative

Upon completion of investigation a follow-up report shall be submitted.

• Brand Name: ATRIUM I-CAST COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; 5 wentworth dr.; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORP.; 5 wentworth dr.; hudson NH 03051
• Manufacturer Contact: james zorabedian, coordinator ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3624785
• MDR Text Key: 17838848
• Report Number: 1219977-2014-00004
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 10893423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK FLEXORSHEATH
• Patient Outcome(s): Required Intervention