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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PFO OCCLUDER; CARDIAC OCCLUSION DEVICE
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AGA MEDICAL CORPORATION AMPLATZER PFO OCCLUDER; CARDIAC OCCLUSION DEVICE Back to Search Results
Model Number 9-PFO-030
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2018
Event Type  Injury  
Event Description
On (b)(6) 2018, a 30mm amplatzer pfo occluder was selected for implant.The distal disc deployed deformed, tire shaped, and would not flatten.The physician re-sheathed the device and exchanged it for a 25mm amplatzer pfo occluder (lot number: 6476529) without issue.No patient consequences were reported.
 
Manufacturer Narrative
The reported event of deformity upon deployment could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
 
Event Description
On (b)(6) 2018, a 30mm amplatzer pfo occluder was selected for implant.The distal disc deployed deformed, tire shaped, and would not flatten.The physician re-sheathed the device and exchanged it for a 25mm amplatzer pfo occluder (lot number: 6476529) without issue.The patient remained hemodynamically stable throughout the procedure and no patient consequences were reported.Per user, the event was not significantly extended.
 
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Brand Name
AMPLATZER PFO 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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8051525
MDR Text Key126550873
Report Number2182269-2018-00137
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P120021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/11/2019
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 Health Professional
Device Expiration Date05/31/2023
Device Model Number9-PFO-030
Device Catalogue Number9-PFO-030
Device Lot Number6489978
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/22/2018
Initial Date FDA Received11/08/2018
Supplement Dates Manufacturer Received12/12/2018
Supplement Dates FDA Received01/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2018
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) Other; Required Intervention;
Patient Age55 YR
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