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

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

After successful deployment of a stent, the doctor had difficulties removing the deflated balloon through the introducer sheath.The balloon was stuck inside the introducer sheath and eventually became separated from the catheter shaft during pull out.This is the doctor's first case.

Manufacturer Narrative

A review of the complaints database reveals no other reports received on this device lot number.A follow up report will be submitted at the completion of the investigation into this event.

• Brand Name: ADVANTA V12
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin, mgr ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3688048
• MDR Text Key: 16681660
• Report Number: 1219977-2014-00052
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/18/2012

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2012
• 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
• Treatment: 7FR TERUMO SHEATH
• Patient Outcome(s): Required Intervention