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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION ATRIUM ADVANTA V12 LARGE DIAMETER COVERED STENT; PTFE COVERED STENT Back to Search Results
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.
 
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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 Key5989739
MDR Text Key55990747
Report Number1219977-2016-00209
Device Sequence Number1
Product Code PNF
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
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 Received09/30/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/19/2016
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 Number1
Patient Outcome(s) Required Intervention;
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