Citation: masters rg, et al.Extrinsic obstruction of the medtronic-hall disk valve in the mitral position.Ann thorac surg.1988 fe b;45(2):210-2.Doi: 10.1016/s0003-4975(10)62440-x.Earliest date of publish used for date of event: february 1, 1988 (month and year valid).No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information from a literature article regarding three cases of extrinsic obstruction of the medtronic-hall prosthesis in the mitral position.Patient 1: a (b)(6) -year-old female patient who underwent mitral valve replacement with a 29 mm medtronic-hall mechanical valve using an interrupted mattress suture technique of ethibond buttressed with teflon pledgets.The valve seated well, with free movement of the disk occluder.The patient was weaned from cardiopulmonary bypass without difficulty.However, during closure of the sternotomy, hypotension occurred with electromechanical dissociation, necessitating reinstitution of cardiopulmonary bypass.The left atrium was re-opened, and the disk occluder was found to be firmly stuck in the closed position.One suture had torn through the friable anterolateral mitral annulus and was overhanging and had become lodged between the valve ring and disk, jamming the valve in the closed position.The disk was released manually, and the valve was re-sutured with considerable difficulty.Despite intra-aortic balloon counter-pulsation and dopamine therapy, the patient could not be weaned from cardiopulmonary bypass.The authors did not explicitly state the patient¿s outcome, but based on the given circumstances, it is likely the patient died.Patient 2: a (b)(6) -year-old female patient who underwent mitral valve replacement with a 29 mm medtronic-hall mechanical valve.Although the valve disk moved freely, during closure a sudden drop in blood pressure occurred with electromechanical dissociation.The left atrium became noticeably distended.Cardiopulmonary bypass was reinitiated, and the atrium was re-opened.The tip of the posteromedial papillary muscle was wedged between the disk and valve ring, locking the valve in the closed position.The valve was opened manually, and the papillary muscle was debrided.The patient was weaned from cardiopulmonary bypass without difficulty and was discharged twelve days later.Patient 3: a (b)(6) -year-old female patient who underwent mitral valve replacement with a 31 mm medtronic-hall mechanical valve.The valve disk was seen to move freely, and the patient was weaned from cardiopulmonary bypass without difficulty.During closure of the sternotomy, recurrent episodes of electromechanical dissociation were noted.With a normal electrocardiogram, there were recurrent episodes of cessation of left ventricular ejection followed by spontaneous recovery.Cardiopulmonary bypass was reinitiated, and the atrium was opened.The tip of the posteromedial papillary muscle was found to lay on the valve ring, causing intermittent locking of the disk against the ring.The papillary muscle was debrided, resulting in a normally functioning valve.The patient was weaned from cardiopulmonary bypass and was subsequently discharged after an uneventful hospital course.No unique device identifier numbers were provided.No additional adverse patient effects or product performance issues were reported.
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