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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHANICAL
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CRYOLIFE, INC. ¿ AUSTIN ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXACE-23
Device Problem No Apparent Adverse Event (3189)
Patient Problem Myocardial Infarction (1969)
Event Type  Injury  
Event Description
According to initial reports, patient who had a bicuspid aortic valve s/p 23mm mechanical on-x valve placed (b)(6) 2016 presented with an nstemi.Inr the week prior had been 1.7, on day of admission inr was 1.4 had goal inr 1.5-2, also on asa 81mg daily.Cath with distal circ branch with occlusion.Fluoro of the valve without any concerns, no evidence of thrombus on tte.
 
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Brand Name
ONX AORTIC CONFORM EXT 23
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
CRYOLIFE, INC. ¿ AUSTIN
1300 e. anderson ln., bldg. b
austin TX 78752
Manufacturer (Section G)
CRYOLIFE, INC. ¿ AUSTIN
1300 e. anderson ln., bldg. b
austin TX 78752
Manufacturer Contact
rochelle maney
1655 roberts blvd
kennesaw, GA 30144
7704193355
MDR Report Key11635828
MDR Text Key244483043
Report Number1649833-2021-00011
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberONXACE-23
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date03/16/2021
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age35 YR
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