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| Model Number ONXM-31/33 |
| Device Problem
Break (1069)
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| Patient Problems
Death (1802); Embolism (1829); Foreign Body In Patient (2687)
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| Event Date 03/28/2017 |
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Event Type
Death
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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 the initial email from the distributor, "i report you the accident happened today about leaflet's escape.One leaflet of mitral 31/33, which implanted on (b)(6) 2013 to the (b)(6) old male, was escaped and trapped at kidney artery.Patient was operated today and replaced to biological valve but escaped leaflet has not yet taken out.The patient condition is not so well he has been under pcps since yesterday when he was delivered as emergency patient." additional information from another representative at (b)(6) indicated the following: "we have received a serious complaint regarding on-x mitral valve from hospital saying that one side of the leaflets was told to be come off or fragmented (still unknown) from the valve housing.Ct scanned picture tells the detached leaflet seems to be staying near renal artery, but doctors are still not sure whether fragmented parts (if there are) in other parts of the body.The patient is a male, who had mvr (on-x m valve) and tricuspid valve plasty at the same time in 2013, being brought to the hospital due to respiratory failure was finally found trouble with the replaced mitral valve.A biological valve was used to replace the troubled valve this time.However, the patient still needs intensive care of stopping bleeding in unpredictable state and doctors are not able to make any prediction of the schedule to remove the half leaflet at this phase.In addition, pcps was initially decided to operate for improving the patient¿s respiratory failure, which made his right leg necrotized and probably expected to be amputated soon.This is outline of the situation and following is what we know now about the patient, valve and hospital.(patient) -male who had mvr and tricuspid valve plasty in 2013 (valve).-on-x mitral valve 31/33.-s/n (b)(4).(hospital) -first mva (2013) in (b)(6) medical center.-this time treatment in (b)(6)." additional information from the distributor indicated sequence of events: ¿(b)(6) [2017] the patient suddenly had acute respiratory distress and ambulanced to the hospital.Initial diagnosis was respiratory failure with lung bleeding.Connected to ventilator and medically treated by physician.On (b)(6) [2017] the patient condition no recovery.On the same day connected to pcps via femoral.Six (6) hours later, due to cannulation the right leg ischemia and starting necrosis.Transferred to the cardiac surgeon and diagnosed acute cardiac insufficiency.3d echo showed mitral valve leaflet escape and reflux, and ct showed suspected escaped leaflet at abdominal aorta.On (b)(6) [2017] a redo surgery done for replacement to a tissue valve (magna mitral 25 mm).Pcps connection changed from femoral access to direct cardiac access (connected to ascending aorta and right atrium).On (b)(6) [2017] still patient condition not recovered, unconsciousness, and bleeding from pcps [percutaneous cardiopulmonary support] connection site.Additional treatment for bleeding completed.Surgeon explained us that the right leg might need to be amputated in future.On (b)(6) [2017] cardiopulmonary condition recovered and pcps will be removed on the same day.The right leg condition recovered slightly and may not need to be amputated.According to the surgeon, the patient brain might have damages due to hypoxia and difficult to recover completely.And kidneys might be damaged due to the right leg ischemia, or renal artery occlusion by the leaflet.The escaped leaflet(or fragmented leaflet) will be removed after the patient recovery, which will be at least 2-3 months later.The surgeon agreed to return us the escaped leaflet for cryolife¿s investigation.On (b)(6) [2017] after weaning of central ecmo [extracorporeal membrane oxygenation], progress of metabolic acidosis was observed although blood inflow to lower limbs and enteron were good.Cause unknown.Gradually recovered.Both cpk [creatinine phosphokinase] and k [potassium] value peaked out, then recovering.Whole body of the patient was ct scanned.Head ct scanning found cerebral hemorrhage (bleeding from lateral ventricle to fourth ventricle lot of point-like subcortical hemorrhage abdominal ct confirmed that the fractured leaflet was positioned below the renal artery and not interfering with sma [superior mesenteric arteries] and celiac.On (b)(6) [2017] there was a sudden drop of blood pressure.Abdominal bulging and acidosis progress was confirmed.On (b)(6) [2017] emergency operation: examination laparotomy, intestinal resection (left colon resection, ileal resection, cholecystectomy) symptoms progressed and surgical intervention was conducted.Abdominal puncture found stool-like drain.Emergency surgery conducted: perforation on rectal and descending colon, ileal and gallbladder necrosis were found necrosis not ischemia, cause unknown state of peritonitis and sepsis.On (b)(6) [2017] sepsis got out of control.The emergency surgery took place again because intestinal ischemia or necrosis was skeptical.Pcps was reconnected to the patient (connected to the artificial graft attached to the left femoral artery of the patient).The blood circulation became unstable.Laparotomy performed and extensive colon necrosis was recognized.The whole part of colon and the part of small intestine were removed by the surgery after all.On (b)(6) [2017] cardiac arrest had been observed since the previous night.Pcps did not work.The patient was confirmed dead at 10:54 am.; autopsy with family consent.Escaped leaflet found stuck in renal artery in ventral aorta.The leaflet partly broken as if hinge is being chipped.No clue on a location of the fragment at this moment.Damage observed in aorta of where the surface of broken leaflet came in contact.Away from ima (inferior mesenteric artery) and no clotting detected in aorta.¿ additional information is pending and the valve has been returned and is currently being evaluated.
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Manufacturer Narrative
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The distributor asked the following question on (b)(6) 2017, "please teach me the possibility of the aging metallic fatigue which might be happen to the pyrolytic carbon leaflet in case the surgeon had applied too strong tension to the leaflet ends at the hinge when he had tried to rotate the valve after the tight suture of the valve." it was conveyed to them that the sample would be evaluated by a materials expert as well as for elemental and fracture analysis.They state on (b)(6) 2017, "i believe that we need to list up hypothesis as many as possible in order not to affect past onx patients.So that i want to know the any possibility causing any damage to the leaflet during initial valve implant's operation technique by the surgeon.Some not skilled surgeons have tried to rotate the valve after complete suture with heavy stress to the hinge parts.I suppose such heavy stress might create any minor damages which may cause aging metallic fatigue as irregular case." the following questions were asked "to the distributor, responses in quotations: please submit patient medical records from last 6 months, or a statement of procedures in the last 6 months for this patient prior to the discovery of the fractured/dislodged leaflet.- "according to this surgeon, the patient has been treated by the initial hospital since the initial surgery, and no unusual or suspected condition while then.The surgeon is going to write to the hospital where initially on-x valve implanted, to ask your request for patient medical record and a statement of procedures in the last 6 months.For supporting his requisition make, please specify each detail, what and why cryolife needs this record.The surgeon will write to the hospital accordingly." did this patient receive any diagnostic procedure, such as cardiac catheterization within the last 6 months.- "according to the patient¿s family, recently no interventional treatment done." did this patient sustain an impact to the chest wall (such as an automobile accident, or sternal compression for cpr, etc.) that may help explain a compression transmitted to the implanted valve? - "according to the initial investigation when transferred to er, there seems to be no damage or trauma." did this patient receive any invasive procedure that may have contacted the valve during the course of the procedure? "you mentioned that the patient had pcps, and we ask for clarification.Was this cardiopulmonary support being done to treat the symptoms of the valve with only 1 leaflet?" or, was pcps being done before the valve and leaflet problem occurred? -"pcps was done to treat the symptoms of the valve with only 1 leaflet, after this problem occurred." it will be necessary to obtain at least 1 fragment (piece) of the leaflet, but best to have all parts of the fractured leaflet- analysis will be done under high tech visualization techniques (see below).Please confirm if this embolized leaflet if the whole (entire) leaflet (this would be called a leaflet escape); or, are there 2 or more leaflet pieces (fragments) that have embolized down stream (this would be called a leaflet fracture) - "the leaflet was fragmented, and a piece was already sent to cryolife.Currently no rest of fragments found." send removed on-x valve and leaflet fragments in return kit for analysis."the leaflet was fragmented, and a piece was already sent to cryolife.Currently no rest of fragments found." please reference attachments for sample evaluation, pictures, and translated medical records.Class="">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 the initial email from the distributor, "i report you the accident happened today about leaflet's escape.One leaflet of mitral 31/33, which implanted on (b)(6) 2013 to the (b)(6) male, was escaped and trapped at kidney artery.Patient was operated today and replaced to biological valve but escaped leaflet has not yet taken out.The patient condition is not so well he has been under pcps since yesterday when he was delivered as emergency patient." additional information from another representative at (b)(6) indicated the following: "we have received a serious complaint regarding on-x mitral valve from hospital saying that one side of the leaflets was told to be come off or fragmented (still unknown) from the valve housing.Ct scanned picture tells the detached leaflet seems to be staying near renal artery, but doctors are still not sure whether fragmented parts (if there are) in other parts of the body.The patient is a male, who had mvr (on-x m valve) and tricuspid valve plasty at the same time in 2013, being brought to the hospital due to respiratory failure was finally found trouble with the replaced mitral valve.A biological valve was used to replace the troubled valve this time.However, the patient still needs intensive care of stopping bleeding in unpredictable state and doctors are not able to make any prediction of the schedule to remove the half leaflet at this phase.In addition, pcps was initially decided to operate for improving the patient¿s respiratory failure, which made his right leg necrotized and probably expected to be amputated soon.This is outline of the situation and following is what we know now about the patient, valve and hospital.(patient) -male who had mvr and tricuspid valve plasty in 2013 (valve) -on-x mitral valve 31/33 -s/n (b)(4) (hospital) -first mva (2013) in (b)(6)-this time treatment in (b)(6)." additional information from the distributor indicated sequence of events: ¿(b)(6) [2017] the patient suddenly had acute respiratory distress and ambulanced to the hospital.Initial diagnosis was respiratory failure with lung bleeding.Connected to ventilator and medically treated by physician.(b)(6) [2017] the patient condition no recovery.On the same day connected to pcps via femoral.Six hours later, due to cannulation the right leg ischemia and starting necrosis.Transferred to the cardiac surgeon and diagnosed acute cardiac insufficiency.3d echo showed mitral valve leaflet escape and reflux, and ct showed suspected escaped leaflet at abdominal aorta.(b)(6) [2017] a redo surgery done for replacement to a tissue valve (magna mitral 25mm).Pcps connection changed from femoral access to direct cardiac access (connected to ascending aorta and right atrium).(b)(6) [2017] still patient condition not recovered, unconsciousness, and bleeding from pcps [percutaneous cardiopulmonary support] connection site.Additional treatment for bleeding completed.Surgeon explained us that the right leg might need to be amputated in future.(b)(6) [2017] cardiopulmonary condition recovered and pcps will be removed on the same day.The right leg condition recovered slightly and may not need to be amputated.According to the surgeon, the patient brain might have damages due to hypoxia and difficult to recover completely.And kidneys might be damaged due to the right leg ischemia, or renal artery occlusion by the leaflet.The escaped leaflet(or fragmented leaflet) will be removed after the patient recovery, which will be at least 2-3 months later.The surgeon agreed to return us the escaped leaflet for cryolife¿s investigation.(b)(6) [2017] after weaning of central ecmo [extracorporeal membrane oxygenation], progress of metabolic acidosis was observed although blood inflow to lower limbs and enteron were good.Cause unknown.Gradually recovered.Both cpk [creatinine phosphokinase] and k [potassium] value peaked out, then recovering.Whole body of the patient was ct scanned.Head ct scanning found cerebral hemorrhage (bleeding from lateral ventricle to fourth ventricle lot of point-like subcortical hemorrhage abdominal ct confirmed that the fractured leaflet was positioned below the renal artery and not interfering with sma [superior mesenteric arteries] and celiac.(b)(6) [2017] there was a sudden drop of blood pressure.Abdominal bulging and acidosis progress was confirmed.(b)(6) [2017] emergency operation: examination laparotomy, intestinal resection (left colon resection, ileal resection, cholecystectomy) symptoms progressed and surgical intervention was conducted.Abdominal puncture found stool-like drain.Emergency surgery conducted: perforation on rectal and descending colon, ileal and gallbladder necrosis were found necrosis not ischemia, cause unknown state of peritonitis and sepsis.(b)(6) [2017] sepsis got out of control.The emergency surgery took place again because intestinal ischemia or necrosis was skeptical.Pcps was reconnected to the patient (connected to the artificial graft attached to the left femoral artery of the patient).The blood circulation became unstable.Laparotomy performed and extensive colon necrosis was recognized.The whole part of colon and the part of small intestine were removed by the surgery after all.(b)(6) [2017] cardiac arrest had been observed since the previous night.Pcps did not work.The patient was confirmed dead at 10:54 am.Autopsy with family consent.Escaped leaflet found stuck in renal artery in ventral aorta.The leaflet partly broken as if hinge is being chipped.No clue on a location of the fragment at this moment.Damage observed in aorta of where the surface of broken leaflet came in contact.Away from ima (inferior mesenteric artery) and no clotting detected in aorta.¿ see attachments for sample evaluation, translated medical records, and imaging pictures.
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Manufacturer Narrative
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The valve housing and the leaflet were delivered to on-x on 04/03/2017 and a sample review was performed for the onxm-31/33, sn (b)(4), by product engineers, on 03/15/2017 via gross visual examination and sem (scanning electron microscopy) and eds (energy-dispersive x-ray spectroscopy) by a third-party lab, (b)(6) engineering.Materials expert (b)(6) phd., p.E., also evaluated the valve.Third-party analysis indicated that no evidence of metallic instrument contact with the valve was present on the sample.Dr.(b)(6) material evaluation concluded the following: field observations indicated that the leaflet fracture had occurred at an unspecified late post-operative time.Examination of manufacturing and inspection records revealed that valve sn (b)(4) materials, components and assembly had satisfied all applicable quality requirements and performance specifications at the time of manufacture.The as received valve components consisted of the valve orifice with the ¿left¿ leaflet in place and the ¿right¿ leaflet detached.Valve components were decontaminated by soaking overnight in a 10 percent aqueous bleach (sodium hypochlorite) solution and the sewing cuff removed.Because the components were covered with a tightly adherent aldehyde-fixed proteinaceous film, they were cleaned ultrasonically in alconox detergent, scrubbed lightly with a soft bristle brush and then rinsed and dried with ethanol and acetone.The serial (b)(4) was etched on to the orifice ring.Orientation terminology is as follows.Face the orifice serial number with the inflow aspect up and the leaflets oriented parallel to the viewing direction.The serial number surface is ¿front¿ and leaflets ¿right¿ and ¿left¿ relative to the viewer.Fracture had occurred in the right front pivot leaflet tab region of the leaflet.The bulk of the leaflet had been recovered while the small pivot tab fragment was missing.Examination of the orifice and of the orifice right front and right back pivots revealed no apparent damage.The orifice itself was intact and undamaged.Examination of the leaflet fracture revealed an angled ¿compression ridge¿ on the outflow (ventricular) aspect of the leaflet and a relatively flat fracture surface on the inflow (atrial) aspect.A compression ridge occurs because of biaxial stresses at final fracture in bending.Fracture texture at the leaflet inflow leading edge tip (b-datum) was flat and relatively featureless.There were features suggesting chevron marks and a chip focal region of crushing damage.Features were noticed on the inflow aspect of the fracture surface that may represent one or more crack arrest fronts.Discussion-fractographic analysis is consistent with damage being introduced to the valve leaflet in situ by some instrumental manipulation, grasping, probing or pressing at the atrial inflow leading edge (b-datum).A focal chip region of crushing damage shown in figures 5 through 9 resulted from a concentrated high force contact.This crushing damage location is nearly coincident with the apparent fracture origin at the inflow edge.-fracture topography is consistent with leaflet bending during systole, with relatively flat surfaces on the tensile inflow aspect, and angled compression ridges on the outflow aspect.Overall, the fracture progressed from the inflow, leading edge, b-datum origin towards the outflow major radius following the tensile bending stress distribution.When fracture crossed the bending neutral axis, the principal stress became biaxial and the principal stress plane changed to a 45-degree inclination, which produced the compression ridge in final fracture.-it is possible that fracture progression was time related and not instantaneous.Damage introduced to the leaflet during instrumental manipulation could have been subcritical, causing a crack that arrested without instantaneous fracture.This crack may have been stable during healing, and at low activity levels.However, the crack was large enough to propagate by fatigue during subsequent high stress excursions.High stress excursions could be caused by increased patient activity levels, hypertension, invasive procedures or chest compressions.-unlike metals, on-x carbon does not have intrinsic mechanisms for generating damage.Therefore damage, that can propagate by fatigue, must be externally introduced to the carbon during surgery or invasive procedures.Stress levels to introduce damage capable of fatigue are actually within the statistical scatter band for single cycle, instantaneous failure.The valve on-x carbon material, components and assembly satisfied all applicable manufacturing specifications and quality system requirements at the time of manufacture.Focal damage and the fracture origin region location are consistent with damage introduced by manipulation from the atrial aspect.Fracture appearance was characteristic of bending overload.Features, such as possible crack arrest fronts are consistent with a time related propagation of externally introduced damage.The root cause of the leaflet fracture and escape was probably an iatrogenic overstress event that caused significant damage to the valve structural integrity.The manufacturing records for the onxm-31/33, 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.During the investigation no non-conformances or deviations were noted.A review of the available information was performed.The onxm-31/33, sn (b)(4), was implanted (b)(6) 2013 in the mitral position.On (b)(6) 2017 (3 years 189 days post implant), (b)(6) male patient presented to emergency room with sudden onset epigastric pain and respiratory distress; large volume bloody and foamy sputum.Patient was intubated and placed on antibiotics and pulse steroids.An echocardiogram at that time did not find anything dysfunctional about the mitral valve.The patient's condition continued to decline and he was placed on pcps on (b)(6) 2017.The patient suffered right leg ischemia as a complication of the pcps requiring replacement of the femoral catheter.The patient was diagnosed with mitral insufficiency on (b)(6) 2017, however, no unequivocal imaging was reported at that time.Mitral valve failure was confirmed on (b)(6) 2017 and the patient was taken to the or for emergent mitral valve replacement and ascending aorta replacement on (b)(6) 2017 during which one of the leaflets of the on-x valve was noted to be missing.The largest leaflet fragment was later located by ct scan, lodged in the abdominal aorta just below the renal arteries.The patient's condition remained poor with hyperkalemic acidosis, cardiac tamponade , and disseminated intravascular coagulation (dic).The patient was noted to be febrile with an elevated cpk (creatine phosphokinase) on (b)(6) 2017 consistent with compartment syndrome of the ischemic right leg.The patient's pulmonary status improved and he was removed from ecmo on (b)(6) 2017.On (b)(6) 2017 he was noted to have adequate perfusion of the abdomen and lower extremities, however, he remained acidotic.On (b)(6) 2017 (9 days postop) the patient developed sudden shock with abdominal distension and intestinal perforation requiring resection of the descending colon, ileum, and gallbladder with subsequently development of peritonitis and sepsis.The medical record states that the cause of the bowel perforation was not ischemic, but rather was unknown.He underwent further bowel resection on (b)(6) 2017 but developed overwhelming sepsis and was pronounced dead on (b)(6) 2017.The largest leaflet fragment was retrieved on autopsy and returned to manufacturer for analysis.Whole body autopsy is planned and will include an attempt to locate other valve leaflet fragments, but the results of that autopsy are not yet available.A separate engineering analysis of the retrieved leaflet fragment reports the observation of a chipped surface from crushing contact that is most commonly found when metallic instruments are used to manipulate the valve in situ rather than using the holder/handle combination or plastic rotator supplied with the instrument kit.The fracture is consistent with a crack-originating on the opposite side of the leaflet from the chip-that propagated over time (cyclic loading, fatigue).In the words of the report, "focal damage and the fracture origin region location are consistent with damage introduced by manipulation from the atrial aspect." scanning electron microscopy sem failed to find any metallic residue, but this could have been washed away during the 3.5 years in situ or by the cleaning technique prior to sem analysis.The instructions for use (ifu) describe the proper techniques and precautions for implantation of this valve.The sudden presentation of severe pulmonary edema on (b)(6) 2017 is consistent with sudden congestive heart failure.Failure of the mitral valve prosthesis would result in sudden congestive heart failure, however, the mitral valve was noted to be intact by echo on (b)(6) 2017.The echo report is likely in error.The clinical presentation is consistent with acute mitral insufficiency.Numerous medical complications occurred during the hospital admission beginning with the development of an ischemic right leg as a complication of ecmo.The resulting compartment syndrome resulted in rhabdomyolysis and dic.The dic in combination with hypotensive shock likely caused multifocal bowel infarcts leading to perforation.The resulting peritonitis then led to overwhelming sepsis and death.There is nothing in the clinical course to suggest an underlying cause for the leaflet fracture.Additionally, review of translated implant operative notes is unremarkable for a potential root cause of the fracture.Although a definitive root cause for the reported event is unknown, evidence obtained via sample evaluation and third-party expert analysis suggests the root cause of the leaflet fracture was an iatrogenic overstress event during implantation that caused significant damage to the valve structural integrity.This event does not identify additional hazards or modify the probability and severity of existing hazards.
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Event Description
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According to the initial email from the distributor, ¿i report you the accident happened today about leaflet's escape.One leaflet of mitral 31/33, which implanted on (b)(6) 2013 to the (b)(6) male, was escaped and trapped at kidney artery.Patient was operated today and replaced to biological valve but escaped leaflet has not yet taken out.The patient condition is not so well he has been under pcps [percutaneous cardiopulmonary bypass] since yesterday when he was delivered as emergency patient.¿ additional information from another representative indicated the following: "we have received a serious complaint regarding on-x mitral valve from hospital saying that one side of the leaflets was told to be come off or fragmented (still unknown) from the valve housing.Ct [computed tomography] scanned picture tells the detached leaflet seems to be staying near renal artery, but doctors are still not sure whether fragmented parts (if there are) in other parts of the body.The patient is a male, who had mvr [mitral valve replacement] (on-x m valve) and tricuspid valve plasty at the same time in 2013, being brought to the hospital due to respiratory failure was finally found trouble with the replaced mitral valve.A biological valve was used to replace the troubled valve this time.However, the patient still needs intensive care of stopping bleeding in unpredictable state and doctors are not able to make any prediction of the schedule to remove the half leaflet at this phase.In addition, pcps was initially decided to operate for improving the patient¿s respiratory failure, which made his right leg necrotized and probably expected to be amputated soon.This is outline of the situation and following is what we know now about the patient, valve and hospital.(patient) -male who had mvr and tricuspid valve plasty in 2013 (valve) -on-x mitral valve 31/33 [onxm-31/33] -s/n (b)(4) (hospital) -first mva [mitral valve annuloplasty] (2013) in (b)(6) medical center -this time treatment in (b)(6).Additional information from the distributor indicated sequence of events: march 23 [2017] after weaning of central ecmo [extracorporeal membrane oxygenation], progress of metabolic acidosis was observed although blood inflow to lower limbs and enteron were good.Cause unknown.Gradually recovered.Both cpk [creatinine phosphokinase] and k [potassium] value peaked out, then recovering.Whole body of the patient was ct scanned.Head ct scanning found cerebral hemorrhage (bleeding from lateral ventricle to fourth ventricle lot of point-like subcortical hemorrhage abdominal ct confirmed that the fractured leaflet was positioned below the renal artery and not interfering with sma [superior mesenteric arteries] and celiac.On (b)(6) [2017] there was a sudden drop of blood pressure.Abdominal bulging and acidosis progress was confirmed.On (b)(6) [2017] emergency operation: examination laparotomy, intestinal resection (left colon resection, ileal resection, cholecystectomy) symptoms progressed and surgical intervention was conducted.Abdominal puncture found stool-like drain.Emergency surgery conducted: perforation on rectal and descending colon, ileal and gallbladder necrosis were found necrosis not ischemia, cause unknown state of peritonitis and sepsis.On (b)(6) [2017] sepsis got out of control.The emergency surgery took place again because intestinal ischemia or necrosis was skeptical.Pcps was reconnected to the patient (connected to the artificial graft attached to the left femoral artery of the patient).The blood circulation became unstable.Laparotomy performed and extensive colon necrosis was recognized.The whole part of colon and the part of small intestine were removed by the surgery after all.On (b)(6) [2017] cardiac arrest had been observed since the previous night.Pcps did not work.The patient was confirmed dead at 10:54 am.Autopsy with family consent.Escaped leaflet found stuck in renal artery in ventral aorta.The leaflet partly broken as if hinge is being chipped.No clue on a location of the fragment at this moment.Damage observed in aorta of where the surface of broken leaflet came in contact.Away from ima (inferior mesenteric artery) and no clotting detected in aorta.".
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