MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ADVANTA V12 LARGE DIAMETER COVERED STENT; PTFE COVERED STENT

Device Problem Insufficient Information (3190)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received an article titled "experience with the atrium advanta covered stent for aortic obstruction" published in the journal of interventional cardiology.The article assessed the efficacy, safety and clinical outcomes of the advanta v12 covered stent in management of coarctation of the aorta (coa) in 17 patients between october 2009 and february 2012.Per the article the implantation of the advanta v12 stent for the treatment of coa is safe and effective in the early term.Noted in the article were adverse events: 2 patients required unplanned re-intervention.Mild chest pain occurred in 3 patients after implantation, but disappeared within 24 hours.Five children required medication for blood pressure control.

Manufacturer Narrative

Investigation: we are unable to fully investigate this report as no product number, lot number or sample was provided.There is no indication this event is due to a device failure.

• Brand Name: ATRIUM ADVANTA V12 LARGE DIAMETER COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5989739
• MDR Text Key: 55990747
• Report Number: 1219977-2016-00209
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/19/2016
• 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): Required Intervention