Model Number NVTR-25 |
Device Problem
Perivalvular Leak (1457)
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Patient Problems
Stroke/CVA (1770); Embolism/Embolus (4438)
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Event Date 10/21/2022 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2022, a 25mm navitor valve successfully implanted using an unknown flexnav delivery system, in a patient with previously diagnosed vascular disease.The vessel diameter of the patient was deemed acceptable for a right femoral approach.It was noted during procedure that there was one recapture of the 25mm navitor valve because of being deployed too high.E.It was noted that the navitor valve was implanted at a final non-coronary cusp depth of 4mm and the left coronary cusp depth of 5mm below the patient's annulus.The valve was successfully implanted and the delivery system was successfully removed.The patient had remained hemodynamically stable throughout the procedure.There was a noted trivial perivalvular leak around the navitor valve and the patient had a single digit gradient.It was also noted during a radiographic examination of he patient's femoral that there was a minor vascular complication due the femoral dissection.The vascular complication was treated using an an unknown vascular balloon.A final digital angiogram of the vessel showed the dissection flap had been repaired and normal flow through the vessel had been resumed.The patient was sent to the catherization lab for recovery.It was noted that the patient was slow to wake up during recovery.A computed tomography brain scan was performed and discovered a calcium fragment in the anterior cerebral artery.The decision was made not to perform an embolic retrieval procedure.The patient was transferred to the stroke recovery unit to recover.
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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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Manufacturer Narrative
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An event of minor vascular complication due the femoral dissection and patient death was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.D6b - explant date: removed date.
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Event Description
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Subsequent to the previously filed report, additional information was received.The dissection caused a delay in procedure.The 25mm navitor valve had been sized using 3-mensio computed tomography imaging.No hemodynamic compromised was reported.It was noted that a non-abbott sheath caused the vascular dissection.It was reported that the patient is deceased.The cause of death was a combination of stroke and the patient's patient¿s comorbidities.The patient's date of death was (b)(6) 2022.It was noted that the 25mm navitor valve was functioning as intended prior to the patient's death.
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Search Alerts/Recalls
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