ST. JUDE MEDICAL, INC. PORTICO NG VALVE, 35MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number PRT-NG-35 |
Device Problem
Retraction Problem (1536)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967)
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Event Date 11/03/2021 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2021, a 25mm navitor valve was selected for implant using a large flexnav delivery system.During procedure, the valve was deployed at 80%, however it was too high and needed to be re-sheathed, however it was "extremely difficult to re-sheath the valve." the valve was re-sheathed once, however not "all the way to the nose-cone." the valve was successfully implanted, however aortic dissection was reported.The patient was hemodynamically stable throughout the procedure.Post-procedure, while in the recovery room, the patient developed acute onset of delirium and transient right arm weakness.Stroke call was activated, however ct head was negative for acute vessel occlusion or hemorrhage; no treatment was required.In addition.The patient became hypotensive 90/50 and received medication.On (b)(6) 2021, increased troponin was observed, however no treatment was required.The patient was reported to be recovering.Clinical study patient id: (b)(6).
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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It was reported that on 3 november 2021, a 25mm navitor valve was selected for implant using a large flexnav delivery system.During procedure, the valve was deployed at 80%, however it was too high and needed to be re-sheathed, however it was "extremely difficult to re-sheath the valve." the valve was re-sheathed once, however not "all the way to the nose-cone." the valve was successfully implanted, however aortic dissection was reported.The patient was hemodynamically stable throughout the procedure.Post-procedure, while in the recovery room, the patient developed acute onset of delirium and transient right arm weakness.Stroke call was activated, however ct head was negative for acute vessel occlusion or hemorrhage; no treatment was required.In addition.The patient became hypotensive 90/50 and received medication, and the patient was diagnosed with hypercapnia.On 4 november 2021, increased troponin was observed, however no treatment was required.The patient was reported to be recovering.
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Manufacturer Narrative
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Additional information sections: b5, h6, h10.An event of difficulty in re-sheathing the valve during deployment and transient right arm weakness were reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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