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
Model Number 85353
Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 03/18/2015
Event Type  Injury  
Event Description
During a fenestrated endovascular aneurysm repair the stent was unable to be advanced through the check flo valve of the sheath.It was dislodged from the balloon after passing through the valve.The sheath was replaced and a new stent was used successfully.
 
Manufacturer Narrative
On completion of the investigation, a f/u report will be submitted.Associated file: 1219977-2015-00089.
 
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 Key4634837
MDR Text Key5572025
Report Number1219977-2015-00088
Device Sequence Number1
Product Code NIN
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2017
Device Model Number85353
Device Catalogue Number85353
Device Lot Number217995
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
COOK 6FR ANSEL SHEATH
Patient Outcome(s) Required Intervention;
-
-