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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER CRIBRIFORM OCCLUDER; CARDIAC OCCLUSION DEVICE
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AGA MEDICAL CORPORATION AMPLATZER CRIBRIFORM OCCLUDER; CARDIAC OCCLUSION DEVICE Back to Search Results
Model Number 9-ASD-MF-025
Device Problem Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Date 05/05/2014
Event Type  Injury  
Event Description
A 25mm amplatzer cribriform occluder (aco) was implanted in the patient's patent foramen ovale (pfo); however, two weeks later the aco did not appear to be sitting properly in the defect and was explanted.The pfo was surgically repaired.
 
Manufacturer Narrative
The results of this investigation are inconclusive because the product was not returned for analysis.Also, the device's manufacturing records could not be reviewed since the lot number was not provided.The cause of the reported event remains unknown.
 
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Brand Name
AMPLATZER CRIBRIFORM 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 Key3820089
MDR Text Key4451639
Report Number2135147-2014-00043
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/05/2014
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-MF-025
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/05/2014
Initial Date FDA Received05/20/2014
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;
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