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ST. JUDE MEDICAL PUERTO RICO, B.V. SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL
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| Model Number 27MECJ-502 |
| Device Problem
Device Dislodged or Dislocated (2923)
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| Patient Problems
Death (1802); Pulmonary Edema (2020)
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| Event Date 03/13/2019 |
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Event Type
Death
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Manufacturer Narrative
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Investigation results will be provided in a subsequent submission.
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Event Description
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Seventeen years ago, a patient received a 19mm mechanical heart valve (manufacturer unconfirmed) in the mitral position.The patient was diagnosed with severe mitral stenosis, atrial flutter and pulmonary hypertension.On (b)(6) 2019, a 27mm masters valve (sn: (b)(4)) was selected as a replacement.The patient was started on ecmo support via femoral access due to pulmonary edema.On (b)(6) 2019, clotting in the plural space was noted and the patient was brought back to the operating room.In the operating room, the leaflet was observed to have dislodged and was pressed against the aortic valve on the ascending aorta side.The valve was removed and the piece was collected and a new 27mm masters valve (sn: (b)(4)) was implanted.Additional information has been requested.
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Event Description
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Seventeen years ago, a patient received a 19mm mechanical heart valve (manufacturer unconfirmed) in the mitral position at the age of seven.The patient was diagnosed with severe mitral stenosis, atrial flutter and pulmonary hypertension.On (b)(6) 2019, a 27mm masters valve ((b)(4)) was selected as a replacement.The patient was started on ecmo support via femoral access due to pulmonary edema.On (b)(6) 2019, clotting in the plural space was noted and the patient was brought back to the or.In the or, the leaflet was observed to have dislodged and was pressed against the aortic valve on the ascending aorta side.The valve was removed and the piece was collected and a new 27mm masters valve ((b)(4)) was implanted.During the procedure, the patient went into right heart failure and on (b)(6) 2019, the patient expired due to pulmonary failure.
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Manufacturer Narrative
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An event of a clotting in the pleural space and an observation that a leaflet had dislodged one day after implant was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.This was inclusive of a review of the leaflet and orifice dimensional matching data was performed and found to be compliant and conforming with the established dimensional matching requirements.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Manufacturer Narrative
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The initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided.The correct mfr number is (b)(4).
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Event Description
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Seventeen years ago, a patient received a 19mm mechanical heart valve (manufacturer unconfirmed) in the mitral position at the age of seven.The patient was diagnosed with severe mitral stenosis, atrial flutter and pulmonary hypertension.On (b)(6) 2019, a 27mm masters valve (sn: (b)(4)) was selected as a replacement.The patient was started on ecmo support via femoral access due to pulmonary edema.During that night, the patient hemorrhaged overnight, but remained hemodynamically stable on low does inotropic support.An echocardiogram was performed revealing a hemothorax.The physician decided to return the patient to the or.In the or, the leaflet was observed to have dislodged and was pressed against the aortic valve on the ascending aorta side.The valve was removed and the piece was collected and a new 27mm masters valve (sn: (b)(4)) was implanted.During the procedure, the patient went into right heart failure and on (b)(6) 2019, the patient expired due to pulmonary failure.
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Event Description
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A 28-year-old man with a history of congenital heart disease underwent a mitral valve replacement with a 19mm mechanical heart valve combined with a ventricular septal defect (vsd) closure at the age of 7 years in mexico city.The patient presented with severe stenosis of the mitral valve prosthesis in combination with severe pulmonary hypertension causing symptoms and the need for surgical intervention.The patient was taken to the operating room on (b)(6) 2019 for a redo-sternotomy and a repeat mitral valve replacement using a 27mm mechanical heart valve (masters series 27mec-j-502; sn# (b)(4)).The patient developed soon after coming off cardiopulmonary bypass right ventricular (rv) failure with subsequent development of flash pulmonary edema and acute respiratory failure requiring immediate institution of venous-arterial-extra-corporeal membrane oxygenation (va-ecmo) using the right femoral venous and arterial cannulas.The new mitral valve prosthesis appeared to be functioning normally with good leaflet motion and no periprosthetic regurgitation at the completion of this procedure.Post-operatively the patient hemorrhaged overnight but remained hemodynamically stable on low dose inotropic support, relatively stable pressor support, va-ecmo while receiving ongoing blood products.The patient was returned to the operating room on (b)(6) 2019 for evaluation of a hemothorax.Intraoperative trans-esophageal echocardiography (tee) identified only one moving leaflet in the mitral valve, and after further assessment and re-exploration while on cardiopulmonary bypass it was discovered that one of the mechanical heart valve leaflets dislodged (escaped) and was sitting on top of the aortic valve leaflets.The dislodged leaflet and rest of the mitral valve prosthesis were removed, and a new 27 mm mechanical mitral valve was implanted (masters series 27mec-j-502; sn# (b)(4)).The patient could not be weaned off ecmo and had to remain on va-ecmo post-operatively.
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Manufacturer Narrative
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Additional information for b2, b5, d10, g4, g7, h1, h2, h3, h6 and h10.The 27mm masters valve was chosen to replace a 19mm mechanical in a patient with multiple comorbidities, including obesity and congenital heart disease, due to patient-prosthetic mismatch.The device was successfully implanted following debridement of the annulus.One day later a leaflet was noted to be dislodged and the patient later expired.Information was received from the field indicating that "the back of a q-tip was gently used to test the leaflet opening and a small pediatric 8 french clear silastic catheter was passed temporarily through the middle of the valve during the implant procedure to decompress the left ventricle." per the instructions for use, artmt100122073 rev.A, "do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications.Use a st.Jude medical¿ leaflet tester to gently test valve leaflet mobility." "do not pass catheters or other instruments through st.Jude medical¿ mechanical heart valves.This could result in scratched or damaged valve components, or leaflet fracture or dislodgment." however, as the device reportedly functioned normally until an intra-operative tee for evaluation of hemothorax indicated the leaflet dislodgement, it can not be conclusively determined if there was any relationship between the use of a q-tip and catheter to the subsequent dislodgement.No damage or other visual anomalies, including during x-ray analysis, were found upon receipt.The leaflet was re-inserted into the orifice and met functional specifications, including no leaflet dislodgement under varied pulsatile flow conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures. this was inclusive of a review of the leaflet and orifice dimensional matching data, which was found to be compliant and conforming with the established dimensional matching requirements.The root cause of the leaflet dislodgement could not be conclusively determined.
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Event Description
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A 28-year old man with a history of congenital heart disease underwent a mitral valve replacement with a 19mm mechanical heart valve combined with a ventricular septal defect (vsd) closure at the age of 7 years in mexico city.The patient presented with severe stenosis of the mitral valve prosthesis in combination with severe pulmonary hypertension causing symptoms and the need for surgical intervention.The patient was taken to the operating room on (b)(6) 2019 for a redo-sternotomy and a repeat mitral valve replacement using a 27mm mechanical heart valve (masters series 27mec-j-502; sn# (b)(6)).The patient developed soon after coming off cardiopulmonary bypass right ventricular (rv) failure with subsequent development of flash pulmonary edema and acute respiratory failure requiring immediate institution of venous-arterial-extra-corporeal membrane oxygenation (va-ecmo) using the right femoral venous and arterial cannulas.The new mitral valve prosthesis appeared to be functioning normally with good leaflet motion and no periprosthetic regurgitation at the completion of this procedure.Post-operatively the patient hemorrhaged overnight but remained hemodynamically stable on low dose inotropic support, relatively stable pressor support, va-ecmo while receiving ongoing blood products.The patient was returned to the operating room on (b)(6) 2019 for evaluation of a hemothorax.Intraoperative trans-esophageal echocardiography (tee) identified only one moving leaflet in the mitral valve, and after further assessment and re-exploration while on cardiopulmonary bypass it was discovered that one of the mechanical heart valve leaflets dislodged (escaped) and was sitting on top of the aortic valve leaflets.The dislodged leaflet and rest of the mitral valve prosthesis were removed, and a new 27 mm mechanical mitral valve was implanted (masters series 27mec-j-502; sn# (b)(6)).The patient could not be weaned off ecmo and had to remain on va-ecmo post-operatively.The patient post-operatively while on va-ecmo continued to receive mass transfusion for bleeding and was returned again to the operating room on (b)(6) 2019 for evacuation of a hemothorax.The patient remained subsequently hemodynamically stable with ecmo but went on to develop severe acute respiratory distress syndrome (ards) presumably due to transfusion related acute lung injury (trali) in addition to severe pulmonary edema.In an effort to improve pulmonary function the patient was taken to the operating room on (b)(6) 2019 and underwent placement of a left ventricular assist device (impella 5.0) via the left axillary artery with the goal of decompressing the left ventricle.The patient subsequently developed harlequin syndrome concerning for brain hypoxia; and therefore, underwent additionally on (b)(6) 2019 placement of a right ventricular assist device via the right internal jugular vein (protek duo rvad-ecmo).On (b)(6) 2019 the patient was started on continuous renal replacement therapy (crrt).The patient hemodynamic status began to improve; however, the patient continued to suffer from severe ards.On (b)(6) 2019 the patient was taken to the operating for removal of the femoral va-ecmo while continuing support with the rvad-ecmo and impella.However, his elevated pulmonary vascular resistance over time caused recirculation of the rvad across the pulmonary and tricuspid valves which lead to poor right to left cardiac output and ultimately to cardiovascular collapse.Re-institution of va-ecmo was felt to be futile at this point and subsequently the patient expired on post-operative day #9 ((b)(6)2019).
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