MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ADVANTA V12; PTFE COVERED STENT

Model Number 85339

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2014

Event Type  Injury  

Event Description

The report states that the physician was performing a thoracic endovascular aneurysm repair with right carotid stenting.The right carotid was attempted first.An 8fr introducer sheath was placed in the right brachial artery.The surgeon reached the target and the 9mm x 59mm stent was advanced over the wire.The right carotid had a very sharp angle and the stent dropped off the catheter to the aortic arch due to the angle.After that the surgeon was able to snare the stent from the aorta through a right femoral artery approach.No harm came to the patient.

Manufacturer Narrative

On completion of evaluation a f/u report will be submitted.

• Brand Name: ATRIUM ADVANTA V12
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645470
• MDR Report Key: 4337977
• MDR Text Key: 5180024
• Report Number: 1219977-2014-00380
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2014

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 Expiration Date: 07/31/2017
• Device Model Number: 85339
• Device Catalogue Number: 85339
• Device Lot Number: 213042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2014
• Initial Date FDA Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Required Intervention
• Patient Age: 70 YR