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; 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; PTFE COVERED STENT Back to Search Results
Model Number 85336
Device Problems Entrapment of Device (1212); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2014
Event Type  Injury  
Event Description
It was reported that the stent could not be fully expanded.The physician removed the balloon but it got trapped in the guide catheter and everything had to be removed as a whole.A new guide catheter was placed and the stent was correctly expanded with a percutaneous transluminal angiography balloon.The device was properly deployed at the target location.The pt was not harmed.
 
Manufacturer Narrative
On completion of the eval a follow up report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATRIUM ADVANTA V12
Type of Device
PTFE COVERED STENT
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
lynda mclaighlin
5 wentworth dr.
hudson, NH 03051
6038645470
MDR Report Key4381067
MDR Text Key5240095
Report Number1219977-2014-00401
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2017
Device Model Number85336
Device Catalogue Number85336
Device Lot Number213572
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-