MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC HEART VALVE WITH ANATOMIC SEWING RING AND EXTENDED HOLDER 23MM; HEART-VALVE, MECHANICAL

Model Number ONXANE-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Organ Dehiscence (2502)

Event Date 02/07/2017

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 the report, "original implant (b)(6) 2016.A (b)(6) male, valve dehiscence.Pt currently has aortic stenosis, mild mr [mitral regurgitation], ef [ejection fraction] 30.On original procedure pt.Enlarged aorta, root enlargement was performed and 23 mm valve was implanted.Valve dehiscence present, redo surgery (b)(6) 2017." the rep also stated, "the surgeon does not believe anything is wrong with the valve, more so the patient's anatomy.The valve has dehisced" and "the surgeon stated the patient presented with shortness of breath, no white count, no fever.He did culture the explanted valve.Following explant the surgeon replace the 23 mm with a onxace 27/29.He stated that he believes the 23 mm was too small of valve for this patient and that is why it dehisced.".

Manufacturer Narrative

Per the surgeon, "the patient is doing well.Culture report should follow in the next few days.¿ via email on 03/13/2017, the rep stated ¿i was informed today that the culture came back negative and there is no further information to add.¿ additionally, the valve was not returned for evaluation.The manufacturing records for the onxane-23, 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.During the investigation no non-conformances or deviations were noted.The onxane-23, sn (b)(4), was implanted (b)(6) 2016 in the aortic position of a (b)(6) male which was explanted and replaced with an onxace-27/29 on (b)(6) 2017 (316 days postop).A report from the site states reasons for the explanting procedure as "shortness of breath, no white count, no fever." tissue cultures came back negative.Surgeon further stated belief that the original 23 mm valve was too small for this patient and that is why it dehisced.Dehiscence in this case indicates that the valve cuff was separating from the aortic annular tissue.The replacement procedure was successfully completed and the patient is doing well.Separation of the cuff from the tissue is generally the result of deteriorating tissue due to infection.However, cultures came back negative and the surgeon made no mention of such deterioration, but rather that the valve size was too small for the patient.This deduction implies that the small size valve placed undue strain on the suture/tissue interface until the sutures eventually worked their way through the annular tissue and lost their grip.The solution was to implant a larger size valve, thereby reducing the strain on the suture/tissue interface.No mention is made of using pledgeted sutures, so we do not know whether or not this would have made any difference in anchoring the sutures.The evidence presented is strongly suggestive of prosthesis-patient mismatch, as described and discussed by pibarot and dumesnil in 2006, who reported it as a common outcome in 20-70% of all aortic prosthetic valve replacement cases [pibarot 2006].This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the report, "original implant (b)(6) 2016.(b)(6) male, valve dehiscence.Pt currently has aortic stenosis, mild mr [mitral regurgitation], ef [ejection fraction] 30.On original procedure pt.Enlarged aorta, root enlargement was performed and 23 mm valve was implanted.Valve dehiscence present, redo surgery (b)(6) 2017." the rep also stated, "the surgeon does not believe anything is wrong with the valve, more so the patient's anatomy.The valve has dehisced" and "the surgeon stated the patient presented with shortness of breath, no white count, no fever.He did culture the explanted valve.Following explant the surgeon replace the 23 mm with a onxace 27/29.He stated that he believes the 23 mm was too small of valve for this patient and that is why it dehisced.".

• Brand Name: ON-X AORTIC HEART VALVE WITH ANATOMIC SEWING RING AND EXTENDED HOLDER 23MM
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln, bldg b; austin TN 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln, bldg b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd nw; kennesaw, GA 30144
• MDR Report Key: 6380931
• MDR Text Key: 69159844
• Report Number: 1649833-2017-00021
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXANE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/07/2017
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other