MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDIBLE

Model Number 85417

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2015

Event Type  Injury  

Event Description

The physician was inserting a stent through a 7fr x 70 cm ansel sheath over a rosen wire that was in an aneurysmal celiac artery.As they got to the end of the sheath, they saw the stent was not on the balloon.The physician advanced it slightly more into the artery and the stent was visible but had slid down on the balloon.The physician stated there was no resistance going through the sheath.He withdrew the catheter and pulled the balloon into the sheath to grab the stent.The entire sheath was removed and a new sheath inserted.No harm came to the patient.

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDIBLE
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645470
• MDR Report Key: 4729603
• MDR Text Key: 5748715
• Report Number: 1219977-2015-00130
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 85417
• Device Catalogue Number: 85417
• Device Lot Number: 221040
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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: 7FR X 70 ANSEL INTRODUCER; ROSEN WIRE 0.035 X 260
• Patient Outcome(s): Required Intervention