Amplatzer? 9-VSDMPIHDE-024

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? 9-VSDMPIHDE-024 manufactured by Aga Medical Corporation.

Event Text Entries

[185979538] 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


[185979539] On (b)(6) 2020, a 24mm amplatzer post infarct vsd occluder in a three day old myocardial infarction. The device was mis-sized too small and pulled through. The patient was put on extracorporeal membrane oxygenation. The defect is planned to be surgically fixed when a bypass surgery is performed on the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2135147-2020-00141
MDR Report Key9908757
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-05
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-05-13
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 ActionPM
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAmplatzer?
Generic NameTRANSCATHETER SEPTAL OCCLUDER
Product CodeMLV
Date Received2020-03-31
Model Number9-VSDMPIHDE-024
Catalog Number9-VSDMPIHDE-024
Lot Number6980608
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. Life Threatening; 2. Other 2020-03-31

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