PERIMOUNT MAGNA EASE AORTIC SIZER 1133

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2009-05-07 for PERIMOUNT MAGNA EASE AORTIC SIZER 1133 manufactured by Edwards Lifesciences.

Event Text Entries

[1158050] Reportedly, device cracked after repeated sterilizations. Being returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5


[15990102] Device evaluation: the cylindrical end and the replica end exhibited cracks at the polyphenylsulfone plastic connection to the handle rod. Only the cylindfical end is attached to the rod. Broken piece is detected at the replica end. Additional information: this evaluation supports the customers claim. Safety risk was evaluated and product risk assessment was conducted. As a result of the risk assessment, capa was opened and has addressed this issue. Customer has been apprised of these actions through follow up correspondence.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2015691-2009-10489
MDR Report Key1375023
Report Source01,06,07
Date Received2009-05-07
Date of Report2009-04-06
Date of Event2009-04-06
Date Facility Aware2009-04-06
Date Mfgr Received2009-06-12
Date Added to Maude2009-06-22
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 FDA0
Event Location3
Manufacturer ContactMR. NEIL LANDRY
Manufacturer StreetONE EDWARDS WAY MAILSTOP: MS HVC96
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492502289
Manufacturer G1EDWARDS LIFESCIENCES LLC
Manufacturer StreetONE EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERIMOUNT MAGNA EASE AORTIC SIZER
Generic NameSIZER, HEART-VALVE, PROSTHESIS
Product CodeDTI
Date Received2009-05-07
Returned To Mfg2009-04-09
Model Number1133
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
10 2009-05-07

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