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 85327
Device Problems Deflation Problem (1149); Material Separation (1562)
Patient Problem No Information (3190)
Event Date 05/07/2015
Event Type  Injury  
Event Description
It was reported that the balloon would not deflate after the stent had been deployed.The radiologist was able to gently manipulate the balloon away from the stent and withdraw the catheter balloon.As the balloon neared the sheath it sheared off the catheter but remained within the sheath and was safely removed.The stent was deployed appropriately.
 
Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
 
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 Key4780305
MDR Text Key21055051
Report Number1219977-2015-00140
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
PMA/PMN Number
K050814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2017
Device Model Number85327
Device Catalogue Number85327
Device Lot Number218652
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/14/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/07/2015
Date Device Manufactured11/01/2014
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;
-
-