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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

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AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE Back to Search Results
Model Number 9-ASD
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067); Thrombus (2101)
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
According to the article "late bacterial endocarditis of an amplatzer atrial septal device" (doi 10.1016/j.Ihj.2013.06.002), a (b)(6) male with an secundum atrial septal defect who was implanted with an amplatzer septal occluder in 2001 was admitted with sepsis and mrsa bacteremia.A transesophageal echo showed presence of an overlying mobile echogenic structure on the left atrial surface of the device suggestive of a vegetation/infected thrombus.The organism isolated in this case was indicative of a nosocomial infection, likely from an infection from an abdominal wound.After initiation of antibiotics, there was significant clinical improvement six weeks later.
 
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Brand Name
AMPLATZER SEPTAL OCCLUDER
Type of Device
CARDIAC OCCLUSION DEVICE
Manufacturer (Section D)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key5081891
MDR Text Key25999655
Report Number2135147-2015-00101
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Physician
Report Date 09/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model Number9-ASD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/16/2015
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;
Patient Age59 YR
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