AMPLATZER? VASCULAR PLUG (UNKNOWN) CVD0105

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-19 for AMPLATZER? VASCULAR PLUG (UNKNOWN) CVD0105 manufactured by Aga Medical Corporation.

Event Text Entries

[184305528] As reported in a research article, seven amplatzer vascular plugs were implanted off-label to attempt to close a pseudoaneurysm. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. Please note, per the instruction for use, artmt600034447 revision b " the amplatzer? Vascular plug and amplatzer? Vascular plug ii are indicated for arterial and venous embolizations in the peripheral vasculature. "
Patient Sequence No: 1, Text Type: N, H10


[184305529] As reported in a research article, a patient presented with repeated bleeding in her neck, she was stable and had no signs of infection or heart failure. On physical examination, there was a small yet actively bleeding cutaneous orifice in the suprasternal notch. Seven amplatzer vascular plugs were implanted off-label to attempt to close a pseudoaneurysm in a patient without success. The physicians completed an endovascular procedure that was able to simultaneously treat the failing aortic valve and the pseudoaneurysm in the ascending aorta, mimicking a bentall-de bono procedure, dubbed the endo-bentall procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2135147-2020-00095
MDR Report Key9857096
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2020-03-19
Date of Report2020-03-19
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-19
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
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMPLATZER? VASCULAR PLUG (UNKNOWN)
Generic NameAMPLATZER VASCULAR PLUG
Product CodeKRD
Date Received2020-03-19
Model NumberCVD0105
Catalog NumberCVD0105
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. Other; 2. Required No Informationntervention 2020-03-19

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