AMPLATZER SEPTAL OCCLUDER 9-ASD-008

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for AMPLATZER SEPTAL OCCLUDER 9-ASD-008 manufactured by Aga Medical Corporation.

Event Text Entries

[186212887] The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10


[186212888] On (b)(6) 2020, an 8mm amplatzer septal occluder (aso) was selected for implant with an 8f torqvue delivery system to close an iatrogenic asd post mitraclip procedure. When attempting to deploy and place the device in the defect, the device assumed a cobra malformation. The physician tried to redeploy the device a couple more times, with no success. The device was removed and exchanged for a 12mm aso (lot #6611991). The 12mm aso was delivered with the same delivery system and placed with no issue. The patient remained stable throughout the procedure and there was no clinically significant delay in the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2135147-2020-00142
MDR Report Key9908850
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-04
Date Mfgr Received2020-03-05
Device Manufacturer Date2018-08-29
Date Added to Maude2020-03-31
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 SEPTAL OCCLUDER
Generic NameTRANSCATHETER SEPTAL OCCLUDER
Product CodeMLV
Date Received2020-03-31
Returned To Mfg2020-03-23
Model Number9-ASD-008
Catalog Number9-ASD-008
Lot Number6611991
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
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 2020-03-31

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