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: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER
  • 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
 

AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Device Problem Biocompatibility (2886)
Patient Problem Embolism (1829)
Event Type  Injury  
Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
Telephone call received today, 2/03/2020, from (b)(6), anesthesiologist at (b)(6), on behalf of a patient, reporting that this issue first occurred 7-8 months ago.¿paradoxical emboli ¿ has continued.Occluder being the problem¿.(b)(6) is pending receipt of part/lot# information from patient.
 
Event Description
On an unknown date, an unknown sized amplatzer septal occluder was selected for implant.It was reported that paradoxical emboli has continued.The patient status is unknown.Additional information was requested, but is not available.
 
Manufacturer Narrative
Additional information sections: b5, h2, h6, h10.An event of paradoxical emboli was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AMPLATZER SEPTAL OCCLUDER
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
MDR Report Key9782063
MDR Text Key183944661
Report Number2135147-2020-00045
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
PMA/PMN Number
P000039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-