ABBOTT MEDICAL NAVITOR TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Catalog Number PRT-NG-29 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atrial Fibrillation (1729); Renal Failure (2041); Heart Block (4444)
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Event Date 02/01/2023 |
Event Type
Injury
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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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Crd_1003 - vantage ide study, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 29mm portico ng valve was implanted.The patient's baseline rhythm is sinus rhythm with first degree atrioventricular block.During the procedure, during valve implantation, the patient experienced 3rd degree heart block and new onset atrial fibrillation.On (b)(6) 2023, a permanent pacemaker was implanted to treat the heart block.On 03 february 2023, the patient was diagnosed with acute kidney failure, however no treatment was required.On (b)(6) 2023, the patient was discharged.
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Manufacturer Narrative
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An event of third degree heart block, acute kidney failure and new onset atrial fibrillation was reported.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 specifications.Based on the available information, the root cause of the reported event 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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Event Description
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Crd_1003 - vantage ide study, patient site id: eu3571 - (b)(6).It was reported that on (b)(6) 2023, a 29mm portico ng was implanted.The patient's baseline rhythm is sinus rhythm with first degree atrioventricular block.During the procedure, during valve implantation, the patient experienced 3rd degree heart block and new onset atrial fibrillation.On (b)(6) 2023, a permanent pacemaker was implanted to treat the heart block.On (b)(6) 2023, the patient was diagnosed with acute kidney failure, however no treatment was required.On (b)(6) 2023, the patient was discharged.
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