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

Model Number 85323

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Hospital reported two events of stent slipped off balloon.

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.Also related report for other event: 1219977-2014-00051.

• Brand Name: ADVANTA V12
• Type of Device: PTFE COVERED SHEET
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin, mgr ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3688026
• MDR Text Key: 17569660
• Report Number: 1219977-2014-00050
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: 85323
• Device Catalogue Number: 85323
• Device Lot Number: 10762206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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