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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFETECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING; HEART-VALVE, MECHANICAL
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ON-X LIFETECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXMC-25/33
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Thrombus (2101)
Event Date 03/21/2019
Event Type  Injury  
Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
 
Event Description
According to initial reports, a usage card received from the hospital lists the status of this implant as disposed as of (b)(6) 2019.A previously submitted implant registration card for this valve shows implant date of (b)(6) 2017.Additional information received notes surgical intervention required as the valve was thrombosed.It was also noted that the patient struggled with maintaining her anticoagulation therapy.
 
Event Description
According to initial reports, a usage card received from the hospital lists the status of this implant as disposed as of (b)(6) 2019.A previously submitted implant registration card for this valve shows implant date of (b)(6) 2017.Additional information received notes surgical intervention required as the valve was thrombosed.It was also noted that the patient struggled with maintaining her anticoagulation therapy.
 
Manufacturer Narrative
The manufacturing records for the onxmc-25/33, sn (b)(4) 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.A review of the available information was performed.Onxmc-25/33 sn (b)(4) was implanted in the mitral position of a 29-year-old female patient on (b)(6) 2017.After a diagnosis of thrombosis- although no objective medical records were made available to confirm this diagnosis-the valve was reported "disposed" (presumed explanted) on (b)(6) 2019 (1 year and 281 days postop).Correspondence with local physicians indicate that patient resides in a rural location and maintenance of adequate anticoagulation is doubtful.But without explicit permission from the patient, no other information would be provided, including history of inr compliance, which, for this valve would nominally be 2.5 - 3.5.The explanted valve was not provided for examination by the manufacturer.This would be a case of valve thrombosis of unknown origin, possibly related to inadequate anticoagulation maintenance, but we do not have enough information to indicate what, if any, relationship the valve has to it.Thrombosis is a rare but known potential complication of prosthetic valve replacement [ifu] occurring at a historical rate of 0.8 % per patient-year for rigid heart valves [iso 5840:2005e].Reoperation and explantation are recognized possibilities as a result of such a complication [ifu).Root cause for this event is probable valve thrombosis of unknown origin, but possibly related to inadequate anticoagulation maintenance.There is not enough evidence to indicate what, if any, relationship the valve has to the occurrence of thrombosis.No further action is warranted at this time.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
ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ON-X LIFETECHNOLOGIES, INC.
1300 e. anderson ln., bldg. b
austin TX 78752
MDR Report Key8461642
MDR Text Key140221948
Report Number1649833-2019-00020
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 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date05/10/2023
Device Model NumberONXMC-25/33
Was Device Available for Evaluation? No
Distributor Facility Aware Date03/25/2019
Date Manufacturer Received03/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age30 YR
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