ONX MITRAL STANDARD 31/33 ONXM-31/33

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-16 for ONX MITRAL STANDARD 31/33 ONXM-31/33 manufactured by Cryolife, Inc. ? Austin.

Event Text Entries

[183564434] This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10


[183564435] According to returned implant notifications from the user facility, onxm-31/33 sn (b)(4) and onxae-25 sn (b)(4) were implanted in the mitral position in the same patient on the same day. This investigation is relegated to onxae-25 sn (b)(4). The onxm-31/33 was the mitral and placed in the mitral position. The onxae-25 was placed as an aortic valve. Patient is deceased. Cause of death - pleural effusion. No additional information forthcoming.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649833-2020-00003
MDR Report Key9836537
Report SourceUSER FACILITY
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-02-04
Date Facility Aware2020-03-11
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-16
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 ContactROCHELLE MANEY
Manufacturer Street1655 ROBERTS BLVD
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal30144
Manufacturer Phone7704193355
Manufacturer G1CRYOLIFE, INC.
Manufacturer Street1300 E. ANDERSON LN., BLDG. B
Manufacturer CityAUSTIN TX 78752
Manufacturer CountryUS
Manufacturer Postal Code78752
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameONX MITRAL STANDARD 31/33
Generic NameHEART-VALVE, MECHANICAL
Product CodeLWQ
Date Received2020-03-16
Model NumberONXM-31/33
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCRYOLIFE, INC. ? AUSTIN
Manufacturer Address1300 E. ANDERSON LN., BLDG. B AUSTIN TX 78752 US 78752


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-03-16

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