MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

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

Patient Problems Embolism (1829); Endocarditis (1834); Hepatitis (1897); Thyroid Problems (2102)

Event Date 02/15/2019

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 returned implant registration cards, patient received onxmc-25/33, sn (b)(4), (b)(6) 2017 in the tricuspid position.Additionally, ircs show the patient received another valve, onxmc-25/33, sn (b)(4), (b)(6) 2019, position not specified.Patient is an iv drug user that stopped her anticoagulation therapy.After the (b)(6) explant surgery, the patient left the hospital before release and without her coumadin prescription.Date of procedure: (b)(6) 2019.Preoperative diagnosis(es): tricuspid mechanical on-x valve endocarditis (recurrent).Status post tricuspid valve replacement for intravenous drug abuse induced tricuspid valve endocarditis ((b)(6) 2017).(b)(6), hypothyroidism, chronic ongoing tobacco abuse, (b)(6) blood cultures, history of septic pulmonary embolism from infected tricuspid valve.Postoperative diagnosis(es): tricuspid mechanical on-x valve endocarditis (recurrent).Status post tricuspid valve replacement for intravenous drug abuse induced tricuspid valve endocarditis ((b)(6) 2017).(b)(6); hypothyroidism; chronic ongoing tobacco abuse; (b)(6) blood cultures.History of septic pulmonary embolism from infected tricuspid valve, procedure: reentry median sternotomy.Explantation of infected on-x tricuspid mechanical valve with multiple vegetations.Implantation of on-x mechanical valve ¿ 25/33 mm on-x valve.Debridement of tricuspid valve annulus and subvalvular area.Intraoperative transesophageal echocardiography.Historical note: this (b)(6) year-old female in (b)(6) 2017 presented with severe tricuspid endocarditis with multiple septic pulmonary emboli into the lungs.After a long course of antibiotics, the patient was put forward for tricuspid valve removal and implantation of a mechanical valve.Unfortunately, the patient continued to use intravenous drugs in spite of finishing a long course of iv antibiotics.She re-presented with endocarditis in 2018 and then re-presented again last month with recurrent evidence of tricuspid valve endocarditis and significant vegetations on the mechanical valve.The patient underwent repeat echocardiograms which continued to show significant vegetations on the mechanical prosthesis with the patient having positive blood culture.She is put forward at this time for repeat open heart surgery.Operative findings; with the patient under general anesthesia, transesophageal echo confirmed the preoperative diagnoses, there was evidence of prosthetic tricuspid obstruction with significant debris and vegetations on the valve as well as in the subchordal apparatus, the mitral valve had mild to moderate insufficiency and ventricular function was well preserved.The patient underwent placement of a sterile field, time-out was called and the previous median sternotomy incision was re-entered with removal of sternal wires.An ima retractor was utilized for anterior retraction of this sternum as adhesions to the posterior sternal table were taken down under direct vision.Reentry was accomplished with an oscillating saw to divide the sternum and there was no injury to the underlying heart or great vessels.Mediastinal adhesions were mobilized and the patient was heparinized.The ascending aorta was cannulated as was the superior and inferior vena cava via the right atrium.On extracorporeal bypass, the patient was maintained at normothermia and the heart was allowed to beat throughout, no aortic cross-clamp was performed.With cable tapes applied, the previous& right atriotomy was reopened; the exposure of the valve was straightforward.The dacron annulus itself was free of any endocarditis or vegetations, but the entire mechanical portion of the valve was infiltrated with vegetation, one-third of the valve orifice was completely obstructed with vegetation while the middle third of the valve, half of it was obstructed with vegetation, both leaflets were fixed in an open position, the last third of the mechanical valve was free of vegetation.The entire valve was completely explanted and all debris around the annulus was completely removed and all material attached to the dacron cuff of the valve was debrided.Throughout this time, the heart was beating and there was never any evidence of heart block.The subchordal apparatus was examined and there were some areas of vegetation attached to chordal elements and these were all excised.Eventually at the completion of this, there were no retained chordal elements in the right ventricle.The annulus was surrounded with horizontal mattress nonpledgeted sutures which were placed through a 25/33 mechanical valve and it was lowered in position and all sutures tied, excellent seating of the valve was accomplished.The right atriotomy was closed and the air was evacuated from the right ventricle and right atrium.Caval tapes were released and the patient was then weaned from extracorporeal bypass.The heart was decannulated without episode and protamine was administered, excellent hemostasis was achieved.The pericardium was closed with interrupted silk sutures and the sternum was approximated with interrupted heavy wire after placement of a 36-freneh chest tube in the pericardial well and the placement of a jp drain in the substernal space.The presternal fascia was closed with a running #1 pds and the skin was closed with a subcuticular 3-0 monocryl.Sponge and needle counts correct.The technical aspects of the procedure were satisfactory and it is hoped the patient will have good operative result.

Manufacturer Narrative

The manufacturing records for the onxm-31/33 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.During the investigation no non-conformances or deviations were noted.Onxmc-25/33 sn (b)(6) was implanted in the tricuspid position of a 29 year old female on may 9, 2017.The patient has a history of endocarditis with intravenous drug abuse as a risk factor.This valve was explanted and replaced by an onxmc-25/33 sn (b)(6) on february 15, 2019 (1 year 281 days post-implant) due to recurrent endocarditis featuring significant debris and multiple vegetation obstructing leaflet motion with subsequent mild to moderate insufficiency.Both leaflets were in a fixed open position due to the vegetation.The instructions for use for the on-x valve acknowledge endocarditis as a potential complication following prosthetic valve replacement, which may lead to re-operation as well as explantation [ifu].In this case, the endocarditis was severe enough to cause non-structural prosthetic valve dysfunction even though the valve itself did not exhibit any inherent abnormality.Root cause for this event is endocarditis leading to non-structural prosthetic valve dysfunction.There is no evidence to suggest that the valve itself contributed to the need for a re-operation.No further action is 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.

Event Description

According to returned implant registration cards, patient received onxmc-25/33 sn (b)(6) (b)(6) 2017 in the tricuspid position.Additionally, ircs show the patient received another valve, onxmc-25/33 sn (b)(6) (b)(6) 2019, position not specified.Patient is an iv drug user that stopped her anticoagulation therapy.After the february 15th explant surgery the patient left the hospital before release and without her coumadin prescription.Date of procedure: (b)(6) 2019 preoperative diagnosis(es): 1.Tricuspid mechanical on-x valve endocarditis (recurrent).2.Status post tricuspid valve replacement for intravenous drug abuse induced tricuspid valve endocarditis(b)(6) 2017).3.Hepatitis c positive.4.Hypothyroidism.5.Chronic ongoing tobacco abuse.6.Methicillin-resistant staphylococcus aureus positive blood cultures.7.History of septic pulmonary embolism from infected tricuspid valve.Postoperative diagnosis(es): 1.Tricuspid mechanical on-x valve endocarditis (recurrent).2.Status post tricuspid valve replacement for intravenous drug abuse induced tricuspid valve endocarditis (b)(6) 2017).3.Hepatitis c positive.4.Hypothyroidism.5.Chronic ongoing tobacco abuse.6.Methicillin-resistant staphylococcus aureus positive blood cultures.7.History of septic pulmonary embolism from infected tricuspid valve, procedure: 1.Reentry median sternotomy.2.Explantation of infected on-x tricuspid mechanical valve with multiple vegetations.3.Implantation of on-x mechanical valve ¿ 25/33 mm on-x valve.4.Debridement of tricuspid valve annulus and subvalvular area.5.Intraoperative transesophageal echocardiography.Historical note: this 30-year-old female in may 2017 presented with severe tricuspid endocarditis with multiple septic pulmonary emboli into the lungs.After a long course of antibiotics, the patient was put forward for tricuspid valve removal and implantation of a mechanical valve.Unfortunately, the patient continued to use intravenous drugs in spite of finishing a long course of iv antibiotics.She represented with endocarditis in 2018 and then re-presented again last month with recurrent evidence of tricuspid valve endocarditis and significant vegetations on the mechanical valve.The patient underwent repeat echocardiograms which continued to show significant vegetations on the mechanical prosthesis with the patient having positive blood culture.She is put forward at this time for repeat open heart surgery.Operative findings; with the patient under general anesthesia, transesophageal echo confirmed the preoperative diagnoses, there was evidence of prosthetic tricuspid obstruction with significant debris and vegetations on the valve as well as in the subchordal apparatus, the mitral valve had mild to moderate insufficiency and ventricular function was well preserved.The patient underwent placement of a sterile field, time-out was called and the previous median sternotomy incision was reentered with removal of sternal wires.An ima retractor was utilized for anterior retraction of this sternum as adhesions to the posterior sternal table were taken down under direct vision.Reentry was accomplished with an oscillating saw to divide the sternum and there was no injury to the underlying heart or great vessels.Mediastinal adhesions were mobilized and the patient was heparinized.The ascending aorta was cannulated as was the superior and inferior vena cava via the right atrium.On extracorporeal bypass, the patient was maintained at normothermia and the heart was allowed to beat throughout, no aortic cross-clamp was performed.With cable tapes applied, the previous& right atriotomy was reopened; the exposure of the valve was straightforward.The dacron annulus itself was free of any endocarditis or vegetations, but the entire mechanical portion of the valve was infiltrated with vegetation, one-third of the valve orifice was completely obstructed with vegetation while the middle third of the valve, half of it was obstructed with vegetation, both leaflets were fixed in an open position, the last third of the mechanical valve was free of vegetation.The entire valve was completely explanted and all debris around the annulus was completely removed and all material attached to the dacron cuff of the valve was debrided.Throughout this time, the heart was beating and there was never any evidence of heart block.The subchordal apparatus was examined and there were some areas of vegetation attached to chordal elements and these were all excised.Eventually at the completion of this, there were no retained chordal elements in the right ventricle.The annulus was surrounded with horizontal mattress nonpledgeted sutures which were placed through a 25/33 mechanical valve and it was lowered in position and all sutures tied, excellent seating of the valve was accomplished.The right atriotomy was closed and the air was evacuated from the right ventricle and right atrium.Caval tapes were released and the patient was then weaned from extracorporeal bypass.The heart was decannulated without episode and protamine was administered, excellent hemostasis was achieved.The pericardium was closed with interrupted silk sutures and the sternum was approximated with interrupted heavy wire after placement of a 36-freneh chest tube in the pericardial well and the placement of a jp drain in the substernal space.The presternal fascia was closed with a running #1 pds and the skin was closed with a subcuticular 3-0 monocryl.Sponge and needle counts correct.The technical aspects of the procedure were satisfactory and it is hoped the patient will have good operative result.

• Brand Name: ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8436169
• MDR Text Key: 139421911
• Report Number: 1649833-2019-00017
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/22/2023
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/07/2019
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 05/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 30 YR