Model Number PVS23 |
Device Problem
Degraded (1153)
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Patient Problems
Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)
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Event Type
Injury
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Event Description
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The manufacturer was informed on this event though the publication ''sutureless and transcatheter aortic valve replacement: when rivals become allies'' by ellouze et al.In the paper, it is reported that sutureless aortic valve replacement (su-avr) and tavr have emerged as viable alternatives to standard surgical avr in higher risk patients.This case series demonstrates that valve-in-valve tavr is feasible in the setting of a degenerated perceval sutureless bioprosthesis, and that su-avr is a useful strategy in the setting of a failed tavr requiring urgent surgery.Case 1 is presented as follows: a (b)(6) year-old woman presented with severe symptomatic aortic regurgitation and stenosis three years after implantation of a medium-sized (23 mm) perceval sutureless prosthesis.The patient was in new york heart association (nyha) functional class iii.Her medical history was significant for type 2 diabetes, obesity, hypothyroidism, hypercholesterolemia, and end-stage renal disease.A decision was made to proceed with tavr rather than reoperation.Given the patient¿s high surgical risk.The procedure was carried out under mild sedation and via a transfemoral approach.Using rapid pacing and transesophageal echocardiographic (tee) guidance, a 26 mm corevalve was successfully deployed inside the degenerated perceval prosthesis with excellent result, and an angioplasty of the left anterior descending artery was concomitantly performed.The mean transaortic gradient decreased from 40 mmhg to 9 mmhg.A pre-discharge echocardiogram showed an aortic valve area (ava) of 1.4 cm2, with trivial regurgitation.The patient was asymptomatic at follow-up 8 months after tavr.
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Manufacturer Narrative
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The manufacturer attempted to retrieve additional information on this event and the device involved.However, no further information has been provided to date.Since the serial number of the device remains unknown, and the device remains implanted, no investigation is possible at this time.Based on the available information, it is not possible to establish a definitive root cause for the reported event.It is possible that the patient¿s clinical history and risk factors (i.E.Type 2 diabetes, obesity, hypothyroidism, hypercholesterolemia, and end-stage renal disease) may have contributed to the structural valve deterioration observed in this perceval s valve.It should be noted that structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.The manufacturer will take further investigative actions and provide an update to this reporting activity should further information be received in the future.
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Search Alerts/Recalls
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