MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ICAST

Model Number 85413

Device Problem Detachment Of Device Component (1104)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

Hold.Ng 3/20/14 doctor advanced the stent into tight, diseased, distal aorta without using fluoroscopy.The stent was advanced beyond the protection of the introducer sheath.The doctor brought the stent back but it was noticed that the stent had moved from the balloon (not between radiopaque markers).The device was snared and brought back to common femoral artery (cfa) for endovascular explant.A surgical excision had to be made to extract stent.

Manufacturer Narrative

We are in the process of performing the investigation.A follow-up report shall be submitted upon completion of the device evaluation.

• Brand Name: ICAST
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin, sr. specialist ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3687839
• MDR Text Key: 4242210
• Report Number: 1219977-2014-00099
• 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: Physician
• Type of Report: Initial
• Report Date: 10/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85413
• Device Catalogue Number: 85413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2013
• Initial Date FDA Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other