Model Number PVS27 |
Device Problems
Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Activation Failure (3270)
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Patient Problem
Aortic Insufficiency (1715)
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Event Date 07/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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Device not available for return.
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Event Description
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On (b)(6) 2019, a pvs27 was implanted in the aortic position.It is reported that the sizing was performed correctly, using the perceval set of sizers.Initially, the valve showed an excellent hemodynamic, with no leaks.However, the post-operative echo control performed on (b)(6) 2019 showed 2 perivalvular leaks, one mild in the non-coronary sinus and one moderate-severe in the right coronary sinus.No stent folding was detected.Consequently, on (b)(6) 2019, a re-operation was performed to explant the pvs27 and replace it with a magna ease 25 mm.The re-do surgery was performed uneventfully and the patient is doing well.It is reported that the patient's native valve was not bicuspid and was heavily calcified.However, no issues occurred intraoperatively with the implant, all the calcification was removed with preservation of the annulus.It is reported that, postoperatively, the valve did not appear as fully expanded.
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Manufacturer Narrative
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As the serial number is unknown and the explanted prosthesis is not available for return, no device investigation can be performed at this time.Based on the available information on the pre-operative dimensions of the annulus (23mm) and the device ultimately implanted in the patient (magna ease 25), the possible root cause of the event can be reasonably associated with a device oversizing, which contributed to the not full expansion of the stent and subsequent perivalvular leak.
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Event Description
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On (b)(6) 2019, a pvs27 was implanted in the aortic position.It is reported that the sizing was performed correctly, using the perceval set of sizers.Initially, the valve showed an excellent hemodynamic, with no leaks.However, the post-operative echo control performed on (b)(6) 2019 showed 2 perivalvular leaks, one mild in the non-coronary sinus and one moderate-severe in the right coronary sinus.No stent folding was detected.Consequently, on (b)(6) 2019, a re-operation was performed to explant the pvs27 and replace it with a magna ease 25mm.The re-do surgery was performed uneventfully and the patient is doing well.It is reported that the patient's native valve was not bicuspid and that it was heavily calcified.However, no issues occurred intraoperatively with the implant, all the calcification was removed with preservation of the annulus.Based on the surgeon's assessment, the valve did not appear as fully expanded, thus it got tilted.Pre-operatively, the aortic annulus measured 23mm.
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Search Alerts/Recalls
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