AMPLATZER CRIBRIFORM OCCLUDER 9-ASD-MF-025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for AMPLATZER CRIBRIFORM OCCLUDER 9-ASD-MF-025 manufactured by Aga Medical Corporation.

Event Text Entries

[184470860] An event of device embolization 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. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[184470861] On (b)(6) 2020, a 25mm amplatzer cribriform occluder was selected for implant. After the device was implanted, the device embolized into the aorta. The device was snared and fully retracted with a goose neck snare. A 24mm amplatzer septal occluder (lot # 6935515) was used to complete the procedure. There were no adverse consequences reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2135147-2020-00130
MDR Report Key9862917
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-03-13
Date Mfgr Received2020-03-13
Device Manufacturer Date2019-10-14
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAMELA YIP
Manufacturer Street5050 NATHAN LANE N
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1AGA MEDICAL CORPORATION
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMPLATZER CRIBRIFORM OCCLUDER
Generic NameTRANSCATHETER SEPTAL OCCLUDER
Product CodeMLV
Date Received2020-03-20
Model Number9-ASD-MF-025
Catalog Number9-ASD-MF-025
Lot Number7224726
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAGA MEDICAL CORPORATION
Manufacturer Address5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-20

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