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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER
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AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Model Number 9-ASD-022
Device Problem Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
On an unknown date, a 22mm amplatzer septal occluder was selected for implant.Prior to deploying the device, a clot was observed in the occluder and the physician elected to exchange the device for another 22mm amplatzer septal occluder (lot number: 5551118).The patient is reported to be stable.
 
Manufacturer Narrative
An event of thrombus noted prior to device deployment was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
On an unknown date, a 22mm amplatzer septal occluder was selected for implant.Prior to deploying the device, a clot was observed in the occluder and the physician elected to exchange the device for another 22mm amplatzer septal occluder (lot number: 5551118).The patient is reported to be stable.
 
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Brand Name
AMPLATZER SEPTAL OCCLUDER
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
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 Key8724780
MDR Text Key148921222
Report Number2135147-2019-00156
Device Sequence Number1
Product Code MLV
UDI-Device Identifier00811806010182
UDI-Public00811806010182
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P000039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Model Number9-ASD-022
Device Catalogue Number9-ASD-022
Device Lot Number6549745
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2018
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
Patient Weight116
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