The date of the event is unknown.According to the article, all implants were completed between december 2016 to february 2018.For this reason, the first day of the range was used as the occurrence date.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-05004.Investigation is ongoing.
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As reported from our affiliates in germany, per article, ''hybrid surgery for severe mitral valve calcification: limitations and caveats for an open transcatheter approach'', a total of six patients with high-grade mitral stenosis were treated with an open implantation of the edwards sapien 3 valve prosthesis.All patients had massive calcification of the posterior mitral valve annulus.A perforation of the ventricle through the tip of the ''delivery system'' was noted on one patient.The perforation was then closed with several sutures.
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Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential adverse events associated with the overall thv procedure and may require intervention.There are several potential etiologies for ventricular perforation during a thv procedure, including perforation by the guidewire, the delivery system, or the transvenous pacer (tvp) lead.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.Per the procedure didactic, patients with small ventricles are at particularly high risk for ventricular perforation.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate patient/procedural factor may have caused or contributed to this event.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Reference article: erik bagaev, ahmad ali, shekhar saha, sebastian sadoni, martin orban , michael naebauer, julinda mehilli , steffen massberg, andreas oberbach and christian hagl.''hybrid surgery for severe mitral valve calcification: limitations and caveats for an open transcatheter approach''.Medicina 2022.
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