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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX MITRAL STANDARD 25; HEART-VALVE, MECHANICAL

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CRYOLIFE, INC. ¿ AUSTIN ONX MITRAL STANDARD 25; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXM-25
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Code Available (3191)
Event Date 10/25/2019
Event Type  malfunction  
Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
 
Event Description
According to initial reports, upon seating the valve, the leaflet was not functioning optimally.The surgeon tried rotating the valve with great difficulty, however the valve was, ultimately not used.
 
Manufacturer Narrative
According to initial reports, the valve leaflet was not functioning optimally.The surgeon tried rotating the valve with great difficulty, however the valve was not used.Additional information was received.The surgeon said he implanted the valve anti-anatomically as per company recommendations.The manufacturing records for the onxm-25 sn (b)(6) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.An evaluation of the returned product was performed.The methods of observation performed were visual, microscopy, physical test.Prior to decontamination, visual examination of valve showed no obvious signs of damage.Both leaflets were freely moving.After decontamination, inspection of the part under the microscope showed no damage to the valve or leaflets.The sewing cuff shows evidence of use where sutures were possibly placed.The part was tested using a size 25 rotator.The rotator was easily able to rotate the part both clockwise and counter-clockwise with no resistance.The issue reported could not be replicated.The leaflets appear to be functioning as intended and the valve rotates freely.Root cause for this event is unknown.No additional actions are required.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
 
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Brand Name
ONX MITRAL STANDARD 25
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
CRYOLIFE, INC. ¿ AUSTIN
1300 e. anderson ln., bldg. b
austin TX 78752
MDR Report Key9321554
MDR Text Key180642276
Report Number1649833-2019-00073
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
PMA/PMN Number
P000037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberONXM-25
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2019
Distributor Facility Aware Date10/29/2019
Initial Date Manufacturer Received 10/29/2019
Initial Date FDA Received11/14/2019
Supplement Dates Manufacturer Received10/29/2019
Supplement Dates FDA Received11/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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