Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ADVANTA V12 COVERED STENT; PTFE COVERED STENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRIUM MEDICAL CORP. ATRIUM ADVANTA V12 COVERED STENT; PTFE COVERED STENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Type  Injury  
Event Description
Received an article titled "fenestrated stent grafting for short-necked and juxtarenal abdominal aortic aneurysm: an 8-year single-centre experience.European journal of vascular and endovascular surgery.2010.39, 259-536.It was a retrospective data collection from november 2001-april 2009.Ptfe covered stents were used in the juxtarenal aneurysm repairs.Per the study, one pt experienced an intraoperative dissection.
 
Manufacturer Narrative
A complete investigation was not able to be performed as no product code, lot number, or sample was provided.Per the study fenestrated stent grafting for short-necked and juxtarenal abdominal aortic aneurysm appears safe and effective on the longer term.Associated files: 1219977-2015-00091; 1219977-2015-00092.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATRIUM ADVANTA V12 COVERED STENT
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 Key4638079
MDR Text Key5618446
Report Number1219977-2015-00090
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Literature
Reporter Occupation Physician
Type of Report Initial
Report Date 03/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2015
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? Yes
Date Manufacturer Received03/13/2015
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;
-
-