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ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER; HEART-VALVE, MECHANICAL
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Back to Search Results |
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| Model Number ONXACE-23 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Corneal Pannus (1447); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Thrombus (2101)
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| Event Date 08/07/2018 |
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Event Type
Injury
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Manufacturer Narrative
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This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
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Event Description
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According to operative notes, preoperative diagnoses: mechanical valve dysfunction due to thrombosis of the mechanical valve, severe mechanical valve stenosis with regurgitation, class iii combined systolic and diastolic congestive heart failure, prior sternotomy.Postoperative diagnoses: mechanical valve dysfunction due to thrombosis of the mechanical valve, severe mechanical valve stenosis with regurgitation, class iii combined systolic and diastolic congestive heart failure, prior sternotomy.Operation performed: urgent redo sternotomy, removal of five sternal wires, removal of 23 nun on-x mechanical valve, redo aortic valve replacement with a 21 mm on-x mechanical valve, swan-ganz catheter placement, exposure of right femoral artery and femoral vein, cardiopulmonary bypass, transesophageal echo, epiaortic ultrasound, bilateral five-level intercostal nerve block with exparel, platelet gel application, vas catheter placement.Anesthesia: general endotracheal anesthesia.Indications and consent: the patient is a (b)(6) gentleman with a history of congenital bicuspid aortic valve.He had a tissue valve placed as a child.That valve deteriorated and he needed a mechanical valve and that was placed five years ago in 2013.He recently decided he did not need to take his coumadin anticoagulation therapy any longer.He then presented with shortness of breath and dyspnea on exertion, underwent evaluation, was found to have severe mechanical valve insufficiency.There was no rocking of the mechanical valve.The valve was intact with no perivalvular leak, but the leaflets were stuck open because of thrombosis.The patient was brought to the hospital, diuresed, placed on heparin anticoagulation therapy and we were consulted to see the patient for surgical evaluation.I saw the patient in consultation.I examined the patient, reviewed his imaging studies.I discussed and recommended surgery to the patient, his wife and mother.I discussed the operation and redo sternotomy with the patient specifically discussing complications, risks, benefits, and alternatives.We discussed the risks of redo sternotomy.He had a ct scan checked, looked at the sternal relationship to his underlying heart failure and we discussed the risk of infection, bleeding, stroke, mi, arrhythmias.We discussed the operative mortality risk of roughly s given the redo nature of the surgery.We discussed the specific need that he must take his coumadin.I initially recommended a tissue valve because of his noncompliance.The mother and the wife assured me that he will take his coumadin as did the patient and they wished to have another on-x valve placed.I contacted the on-x valve rep and he came into town with appropriate supply of on-x mechanical valves.Questions were answered and consent was obtained to proceed with surgery.Intraoperative findings : left ventricular function was well preserved.He came off bypass with low dose inotropes.His preprocedural tee showed severe aortic mechanical valve insufficiency due to thrombosis of the leaflets and immobility of those leaflets.There was no perivalvular leak evident.His mitral valve functioned appropriately with no regurgitation.He had no interatrial septal defects.No clot within the left atrial appendage.Postprocedural tee showed no residual aortic insufficiency or aortic stenosis.Ha had no mitral regurge.No other structural changes in the heart.Overall, ef appeared about 60%.His ascending aorta seen on epiaortic ultrasound, which i independently performed and interpreted based on my surgical plans on showed no atherosclerotic disease of the ascending aorta, just the usual previously operated-on aorta.He had fairly dense adhesions in the pericardium, but pericardium was previously closed.The 23-mm on-x valve was thrombosed with chronic fibrin, debris and subvalvular pannus formation.The left coronary leaflet appeared stuck closed.There may have been some minimal motion, but had a hard time getting it removed with forceps.The right coronary leaflet was stuck open.Pump time was 197 minutes, cross-clamp time 150 minutes, coldest core temperature was 34.1 degree centigrade.Ancef and vancomycin were both administered prior to incision.Iv tylenol and tranexamic acid were administered.Operative procedure: the patient was brought to the operating room, placed on the operating table in the supine position.Right brachial arterial monitoring line was placed.General endotracheal anesthesia accomplished.Foley catheter had difficulty placing it.He had a meatal stricture.I placed the foley myself.I placed a very thin filiform, went through the stricture easily into the bladder and i dilated up.Ultimately, placed a 16-french foley catheter and after dilating, it went in without difficulties.We did get urine bag initially, nice yellow urine and then subsequently during the case, the urine output dropped of£ and urology was consulted at the end of the case, but it is not clear he does not have acute renal insufficiency as he had that preop.A right internal jugular swan-ganz catheter was successfully positioned.The chest, abdomen, groin, and legs were all prepped with duraprep and draped in the usual sterile fashion for a redo sternotomy.Time-out process was carried out appropriately identifying the patient and procedure.The right femoral artery and vein were exposed.I did try to do it percutaneously, but could not get into the artery.So, i did a cutdown onto the femoral artery and placed a vascular loop around the femoral artery.Vein was clearly evident, no further dissection carried out.Subsequently, redo sternotomy was completed uneventfully and no intervention was needed in the right femoral region.Five sternal wires were divided and left in place.Sternotomy completed with oscillating sternal saw down to the wires, first through the anterior leaflet, then the posterior leaflet of the sternum.The wires were then removed and the sternotomy completed uneventfully.Dissection was then completed using sharp dissection and cautery to separate the sternum from the underlying pericardium.This dissection also proceeded uneventfully.The pericardium was opened.The adhesions were taken down.A pericardia cradle was created and a systemic heparin then administered.The aorta was uncovered.Epiaortic ultrasound was completed inspecting the ascending aorta.I see no atherosclerotic disease.The ascending aorta was cannulated for arterial return from the pump.Retrograde cardioplegia line was placed transatrially and a three-stage single venous cannula placed through the right atrial appendage into the inferior vena cava and the patient was placed on bypass.A needle vent was placed in the ascending aorta for aortic cardioplegia and venting and a pursestring was placed in the right superior pulmonary vein for eventual lv vent placement.The method of myocardial protection employed was cold blood cardioplegia given antegrade.Because of his insufficiency, this was abandoned and retrograde cardioplegia administered.Topical flush was applied for cold preservation of myocardium and to aid in cardiac standstill and c02 was used to further fill during the entire case beginning at this point until antegrade perfusion was restored.Ultimately, cardiac standstill was achieved.During retrograde cardioplegia, the aorta was opened obliquely down into the noncoronary sinus.The valve was inspected, the findings as outlined above.The pannus was carefully removed and chronic thrombus was removed from the leaflet.It was evident that just doing this was not going to work because of his subvalvular pannus.I then excised the 23 mm on-x mechanical valve.The annulus was debrided of all the pledgeted material and other dacron material from the graft.The ventricle was irrigated with copious amounts of ice saline.Antegrade direct coronary perfusion was administered on three different occasions during the course of the procedure, although, with retrograde cardioplegia.Blood could be seen corning from both the right and left coronary ostia.The ventricle was irrigated with copious amounts of ice saline during retrograde cardioplegia to prevent any debris going down the coronary arteries.The valve was sized to a 23 mm on-x valve, but after i placed the pledgeted suture, it was only 21 mm, on-x mechanical valve could be seated.A 2-0 ethibond sutures with pledgets were placed concentrically about the valve.Total of thirteen sets of sutures were placed from the pledget down the ventricular side of the annulus.Five in the left coronary, four in each of the other two coronary portion of the sinuses.Again, the ventricle was irrigated.The valve was sized to a 21 mm, which was well within the green region on the effective orifice index chart for on-x valve.The valve was brought to the field.Sutures were placed through the sewing ring.The valve was seated.There was good coarctation to the annulus.The sutures were all then tied each in turn using a core knot.The leaflets were oriented, so that it open towards the left coronary ostia and thus by default the right coronary ostia.Leaflets were freely mobile prior to closing the aorta.After rinsing, the valve was closed with 3-0 prolene suture in a running fashion in two-layer technique.Each suture began at the corners with the pledgeted horizontal mattress suture and then horizontal mattress followed by overall simple suture technique.Each suture tied to itself at about the midpoint.During this timeframe, the patient was systemically rewarmed.A hotshot dose of cardioplegia then administered 500 ml over 3 minutes, half retrograde and rest antegrade and the cross-clamp removed.A complete heart block rhythm returned spontaneously and no cardioversion required.After placing the cross-clamp initially, an lv vent had been placed through the right superior pulmonary vein pursestring and secured.We now used this vent for deairing purposes using transesophageal echo for guidance.This was done after placing temporary epiaortic pacing wires, two on the surface of the right ventricle, two to the anterior atrial groove, brought out through the skin and secured with ethibond suture and the patient was av paced.The retrograde cardioplegia line was removed and the pursestring suture securing it was tied and reinforced with 3-0 prolene suture.At this point, i continued to work on the area in the ventricle and rewarming.The patient was fully rewarmed and no further intracardiac air.The lv vent was removed using the valsalva maneuver and under water, suture securing it was tied and checked for hemostasis, found to be satisfactory.At this point now, we av paced and the patient fully rewarmed on low dose inotropes and the patient was separated from bypass.This was accomplished without further difficulties.I continued to vent through the aorta.The venous cannula was removed and the pursestring suture securing it was tied and reinforced with 3-0 prolene suture in a figure-of-eight fashion.Once there was no further intracardiac air, the aortic vent was removed and the pursestring suture securing it was tied.The aortic cannula was then removed and pursestring suture securing it was tied x2 and reinforced with pledgeted 3-0 prolene suture placed in a horizontal mattress fashion.Protamine was now administered to reverse the heparin effect, returning act towards its baseline.Transesophageal echo showed appropriate function of the new mechanical valve.No perivalvular leaks.At this point, we continued to work on hemostasis until it was found to be satisfactory for closure.Two 32-french chest tubes were placed, one in the posterior pericardium, one in the diaphragm, and the other in the anterior mediastinum and the right pleural cavity was opened.Now, the lung was fused in that area and really could put in the pleural cavity, just placed in the anterior mediastinum.Both secured with ethibond suture and connected to suction drainage device.Platelet progel was placed inside the pericardium as well as in the anterior mediastinum.Platelet-rich gel between the sternum as it was closed.The sternum was re-approximated with stainless steel wires.The intercostal spaces were infiltrated bilaterally at five levels each with a total of 90 ml of a standard exparel solution.Platelet-rich gel between the sternum as it was closed.The sternal wound was irrigated with copious amounts of warm saline and closed in appropriate layers with vicryl suture including subcuticular stitch in the skin.The right groin and right femoral incision was closed in appropriate layers with vicryl suture including subcuticular stitch in the skin.Dry sterile dressing was applied.Then, through left internal jugular approach, vas catheter was placed per anesthesia, secured, and dressing applied.
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Event Description
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According to operative notes, preoperative diagnoses: mechanical valve dysfunction due to thrombosis of the mechanical valve, severe mechanical valve stenosis with regurgitation, class iii combined systolic and diastolic congestive heart failure, prior sternotomy.Postoperative diagnoses: mechanical valve dysfunction due to thrombosis of the mechanical valve, severe mechanical valve stenosis with regur9itation, class iii combined systolic and diastolic congestive heart failure, prior sternotomy.Operation performed: urgent redo sternotomy.Removal of five sternal wires.Removal of 23mm on-x mechanical heart valve, redo aortic valve replacement with a 21mm on-x mechanical valve, swan-ganz cathereter placement, exposure of right femoral artery and femoral vein, cardiopulmonary bypass, transesophageal echo, epiaortic ultrasound, bilateral five-level intereostal nerve block with exparel, platelet gel application, vas catheter placement.Anesthesia:general endotracheal anesthesia.Indications and consent: the patient is a 32-year-old gentleman with a history of congenital bicuspid aortic valve.He had a tissue valve placed as a child.That valve deteriorated and he needed a mechanical valve and that was placed five years ago in 2013.He recently decided he did not need to take his coumadin anticoagulation therapy any longer.He then presented with shortness of breath and dyspnea on exertion, underwent evaluation, was found to have severe mechanical valve insufficiency.There was no rocking of the mechanical valve.The valve was intact with no perivalvular leak, but the leaflets were stuck open because of thrombosis.The patient was brought to the hospital, diuresed, placed on heparin anticoagulation therapy and we were consulted to see the patient for surgical evaluation.I saw the patient in consultation.I examined the patient, reviewed his imaging studies.I discussed and recommended surgery to the patient, his wife and mother.I discussed the operation and redo sternotomy with the patient specifically discussing complications, risks, benefits, and alternatives.We discussed the risks of redo sternotomy.He had a ct scan checked, looked at the sternal relationship to his underlying heart failure and we discussed the risk of infection, bleeding, stroke, mi, arrhythmias.We discussed the operative mortality risk of roughly s given the redo nature of the surgery.We discussed the specific need that he must take his coumadin.I initially recommended a tissue valve because of his noncompliance.The mother and the wife assured me that he will take his coumadin as did the patient and they wished to have another on-x valve placed.I contacted the on-x valve rep and he came into town with appropriate supply of on-x mechanical valves.Questions were answered and consent was obtained to proceed with surgery.Intraoperative findings : left ventricular function was well preserved.He came off bypass with low dose inotropes.His preprocedural tee showed severe aortic mechanical valve insufficiency due to thrombosis of the leaflets and immobility of those leaflets.There was no perivalvular leak evident.His mitral valve functioned appropriately with no regurgitation.He had no interatrial septal defects.No clot within the left atrial appendage.Postprocedural tee showed no residual aortic insufficiency or aortic stenosis.Ha had no mitral regurge.No other structural changes in the heart.Overall, ef appeared about 60%.His ascending aorta seen on epiaortic ultrasound, which i independently performed and interpreted based on my surgical plans on showed no atherosclerotic disease of the ascending aorta, just the usual previously operated-on aorta.He had fairly dense adhesions in the pericardium, but pericardium was previously closed.The 23-mm on-x valve was thrombosed with chronic fibrin, debris and subvalvular pannus formation.The left coronary leaflet appeared stuck closed.There may have been some minimal motion, but had a hard time getting it removed with forceps.The right coronary leaflet was stuck open.Pump time was 197 minutes, cross-clamp time 150 minutes, coldest core temperature was 34.1 degree centigrade.Ancef and vancomycin were both administered prior to incision.Iv tylenol and tranexamic acid were administered.Operative procedure: the patient was brought to the operating room, placed on the operating table in the supine position.Right brachial arterial monitoring line was placed.General endotracheal anesthesia accomplished.Foley catheter had difficulty placing it.He had a meatal stricture.I placed the foley myself.I placed a very thin filiform, went through the stricture easily into the bladder and i dilated up.Ultimately, placed a 16-french foley catheter and after dilating, it went in without difficulties.We did get urine bag initially, nice yellow urine and then subsequently during the case, the urine output dropped of£ and urology was consulted at the end of the case, but it is not clear he does not have acute renal insufficiency as he had that preop.A right internal jugular swan-ganz catheter was successfully positioned.The chest, abdomen, groin, and legs were all prepped with duraprep and draped in the usual sterile fashion for a redo sternotomy.Time-out process was carried out appropriately identifying the patient and procedure.The right femoral artery and vein were exposed.I did try to do it percutaneously, but could not get into the artery.So, i did a cutdown onto the femoral artery and placed a vascular loop around the femoral artery.Vein was clearly evident, no further dissection carried out.Subsequently, redo sternotomy was completed uneventfully and no intervention was needed in the right femoral region.Five sternal wires were divided and left in place.Sternotomy completed with oscillating sternal saw down to the wires, first through the anterior leaflet, then the posterior leaflet of the sternum.The wires were then removed and the sternotomy completed uneventfully.Dissection was then completed using sharp dissection and cautery to separate the sternum from the underlying pericardium.This dissection also proceeded uneventfully.The pericardium was opened.The adhesions were taken down.A pericardia cradle was created and a systemic heparin then administered.The aorta was uncovered.Epiaortic ultrasound was completed inspecting the ascending aorta.I see no atherosclerotic disease.The ascending aorta was cannulated for arterial return from the pump.Retrograde cardioplegia line was placed transatrially and a three-stage single venous cannula placed through the right atrial appendage into the inferior vena cava and the patient was placed on bypass.A needle vent was placed in the ascending aorta for aortic cardioplegia and venting and a pursestring was placed in the right superior pulmonary vein for eventual lv vent placement.The method of myocardial protection employed was cold blood cardioplegia given antegrade.Because of his insufficiency, this was abandoned and retrograde cardioplegia administered.Topical flush was applied for cold preservation of myocardium and to aid in cardiac standstill and c02 was used to further fill during the entire case beginning at this point until antegrade perfusion was restored.Ultimately, cardiac standstill was achieved.During retrograde cardioplegia, the aorta was opened obliquely down into the noncoronary sinus.The valve was inspected, the findings as outlined above.The pannus was carefully removed and chronic thrombus was removed from the leaflet.It was evident that just doing this was not going to work because of his subvalvular pannus.I then excised the 23 mm on-x mechanical valve.The annulus was debrided of all the pledgeted material and other dacron material from the graft.The ventricle was irrigated with copious amounts of ice saline.Antegrade direct coronary perfusion was administered on three different occasions during the course of the procedure, although, with retrograde cardioplegia.Blood could be seen corning from both the right and left coronary ostia.The ventricle was irrigated with copious amounts of ice saline during retrograde cardioplegia to prevent any debris going down the coronary arteries.The valve was sized to a 23 mm on-x valve, but after i placed the pledgeted suture, it was only 21 mm, on-x mechanical valve could be seated.A 2-0 ethibond sutures with pledgets were placed concentrically about the valve.Total of thirteen sets of sutures were placed from the pledget down the ventricular side of the annulus.Five in the left coronary, four in each of the other two coronary portion of the sinuses.Again, the ventricle was irrigated.The valve was sized to a 21 mm, which was well within the green region on the effective orifice index chart for on-x valve.The valve was brought to the field.Sutures were placed through the sewing ring.The valve was seated.There was good coarctation to the annulus.The sutures were all then tied each in turn using a core knot.The leaflets were oriented, so that it open towards the left coronary ostia and thus by default the right coronary ostia.Leaflets were freely mobile prior to closing the aorta.After rinsing, the valve was closed with 3-0 prolene suture in a running fashion in two-layer technique.Each suture began at the corners with the pledgeted horizontal mattress suture and then horizontal mattress followed by overall simple suture technique.Each suture tied to itself at about the midpoint.During this timeframe, the patient was systemically rewarmed.A hotshot dose of cardioplegia then administered 500 ml over 3 minutes, half retrograde and rest antegrade and the cross-clamp removed.A complete heart block rhythm returned spontaneously and no cardioversion required.After placing the cross-clamp initially, an lv vent had been placed through the right superior pulmonary vein pursestring and secured.We now used this vent for deairing purposes using transesophageal echo for guidance.This was done after placing temporary epiaortic pacing wires, two on the surface of the right ventricle, two to the anterior atrial groove, brought out through the skin and secured with ethibond suture and the patient was av paced.The retrograde cardioplegia line was removed and the pursestring suture securing it was tied and reinforced with 3-0 prolene suture.At this point, i continued to work on the area in the ventricle and rewarming.The patient was fully rewarmed and no further intracardiac air.The lv vent was removed using the valsalva maneuver and under water, suture securing it was tied and checked for hemostasis, found to be satisfactory.At this point now, we av paced and the patient fully rewarmed on low dose inotrope5 and the patient was separated from bypass.This was accomplished without further difficulties.I continued to vent through the aorta.The venous cannula was removed and the pursestring suture securing it was tied and reinforced with 3-0 prolene suture in a figure-of-eight fashion.Once there was no further intracardiac air, the aortic vent was removed and the pursestring suture securing it was tied.The aortic cannula was then removed and pursestring suture securing it was tied x2 and reinforced with pledgeted 3-0 prolene suture placed in a horizontal mattress fashion.Protamine was now administered to reverse the heparin effect, returning act towards its baseline.Transesophageal echo showed appropriate function of the new mechanical valve.No perivalvular leaks.At this point, we continued to work on hemostasis until it was found to be satisfactory for closure.Two 32-french chest tubes were placed, one in the posterior pericardium, one in the diaphragm, and the other in the anterior mediastinum and the right pleural cavity was opened.Now, the lung was fused in that area and really could put in the pleural cavity, just placed in the anterior mediastinum.Both secured with ethibond suture and connected to suction drainage device.Platelet progel was placed inside the pericardium as well as in the anterior mediastinum.Platelet-rich gel between the sternum as it was closed.The sternum was re-approximated with stainless steel wires.The intercostal spaces were infiltrated bilaterally at five levels each with a total of 90 ml of a standard exparel solution.Platelet-rich gel between the sternum as it was closed.The sternal wound was irrigated with copious amounts of warm saline and closed in appropriate layers with vicryl suture including subcuticular stitch in the skin.The right groin and right femoral incision was closed in appropriate layers with vicryl suture including subcuticular stitch in the skin.Dry sterile dressing was applied.Then, through left internal jugular approach, vas catheter was placed per anesthesia, secured, and dressing applied.
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Manufacturer Narrative
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Manufacturing records for the onxace-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.A review of the available information was performed.The onxace-23 sn 2091703 was reported as implanted in the aortic position of a 27 year old male on 2013 oct 02.After a diagnosis of valve thrombosis, this valve was explanted and replaced on 2018 aug 07 (4 years 309 days post-implant) with an onxace-21 sn 5237726.The explanted valve was not provided to the manufacturer for examination.The re-operative report was made available.In it the surgeon noted that the patient had indicated he had recently decided he did not need to take his anticoagulant, coumadin®, any more.He subsequently presented with shortness of breath and dyspnea on exertion, which, upon examination was determined to be due to severe mechanical valve insufficiency.This was confirmed during the re-operative surgery with a transesophageal echocardiogram and later visually by observing immobility of leaflets due to thrombosis.The valve was still well-seated with no evidence of paravalvular leak.This is a case of valve thrombosis due to chronically inadequate anticoagulation.The instructions for use [ifu] and american heart association/american college of cardiologists guidelines recommend a therapy of anticoagulant drugs for mechanical heart valves, namely warfarin and aspirin [nishimura 2017].Failure to do so risks the occurrence of complications such as thrombosis and subsequently explantation, both of which are listed in the ifu as potential adverse events.Historically, thrombosis of rigid (i.E.Mechanical) heart valves occurs at a rate of 0.8%/patient-year [iso 5840:2005].Root cause for this event is chronically inadequate anticoagulation therapy leading to valve thrombosis and consequent explantation/ replacement.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.
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