ABBOTT MEDICAL NAVITOR TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Catalog Number PRT-NG-25 |
Device Problem
Malposition of Device (2616)
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Patient Problems
Cardiac Arrest (1762); Obstruction/Occlusion (2422); Heart Block (4444)
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Event Date 11/23/2022 |
Event Type
Death
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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Clinical information: (b)(6) study, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 25mm portico ng/navitor valve was implanted using a flexnav delivery system.On (b)(6) 2022, an electrocardiogram (ecg) was performed which showed left bundle branch block (lbbb).No treatment was performed.On (b)(6) 2022, the patient presented to the emergency department due to continuing discomfort that started a few days prior.A third degree atrioventricular (av) block was detected.The patient then went into cardiac arrest 2 times.A temporary pacemaker was placed.On the same day, a bedside transthoracic echocardiogram (tte) showed left ventricular outflow tract obstruction systolic anterior motion (sam).The patient went into multiorgan failure and was transferred to the intensive care unit (icu) where medication was administered for circulatory collapse.The patient but did not respond well to treatment, so it was withdrawn.On (b)(6) 2022, the patient passed away.No additional information was reported.
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Event Description
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Clinical information: (b)(6).It was reported that on (b)(6) 2022, a 25mm portico ng/navitor valve was implanted using a flexnav delivery system.The patient had severe aortic valve calcium present.The pre-implant echo mean aortic valve gradient was 72mmhg.Heparin was administered.Activated clotting time (act) was 220 seconds.A pre-implant balloon valvuloplasty was performed with a 18mm bard true dilatation balloon with 2 inflations performed.The navitor valve was re-sheathed once due to non-uniform expansion before it was implanted.The valve was fully released.The distance from the non-coronary cusp (ncc) to the ventricular end of the frame was 7.84mm.A post-implant balloon valvuloplasty was performed due to underexpansion of the valve, using a 18mm bard true dilatation balloon with 1 inflation, then using a 22mm osypka vacs iii balloon with 1 inflation.On (b)(6) 2022, an electrocardiogram (ecg) was performed which showed left bundle branch block (lbbb).No treatment was performed.On (b)(6) 2022, the patient presented to the emergency department due to continuing discomfort that started a few days prior.A third degree atrioventricular (av) block was detected.The patient then went into cardiac arrest 2 times.A temporary pacemaker was placed.On the same day, a bedside transthoracic echocardiogram (tte) showed left ventricular outflow tract (lvot) obstruction systolic anterior motion (sam).The cause of the lvot obstruction was believed to be due to high gradient aortic stenosis and left ventricular hypertrophy with thickened sigmoid septum.The physician stated that this phenomena occurs after tavi procedures due to change in hemodynamics, including an acute drop in the left ventricular systolic pressure.The patient went into multiorgan failure and was transferred to the intensive care unit (icu) where medication was administered for circulatory collapse.The patient but did not respond well to treatment, so it was withdrawn.On (b)(6) 2022, the patient passed away.The cause of death was believed to be related to the procedure and patient's comorbidities.There was no allegation of malfunction against the implanted valve.
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Manufacturer Narrative
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An event of left bundle branch block, third degree atrioventricular block and multiorgan failure was reported.It was also reported that the patient went into cardiac arrest two times and left ventricular outflow tract (lvot) obstruction systolic anterior motion.A temporary pacemaker was placed.Possible contributing factors to arrhythmia after a portico valve implant include patient conditions, such as pre-existing arrhythmia, anatomical factors, such as calcification extending beneath aortic annular plane in the interventricular septum, and the depth of implant of the device.The patient had medical history of first degree atrioventricular block, hyperlipidemia, hypertension, severe aortic valve calcification which may have contributed to the reported event of heart block.Information from field indicated the navitor valve was re-sheathed once due to non-uniform expansion before it was implanted.Field indicated that the cause of the lvot obstruction was believed to be due to high gradient aortic stenosis and left ventricular hypertrophy with thickened sigmoid septum.Reportedly, the physician stated that this phenomena occurs after tavi procedures due to change in hemodynamics, including an acute drop in the left ventricular systolic pressure.Reportedly, the cause of death was believed to be related to the procedure and patient's comorbidities.There was no allegation of malfunction against the implanted valve.A returned device assessment could not be performed as the device remains implanted and 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 defined manufacturing specifications.Based on the information received, the root cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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