H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
|
It was reported that a 19mm 8300ab aortic valve was explanted on postoperative day (pod) #8 due to paravalvular leak (pvl) caused by technical issue of suturing and insufficient debridement of calcification.The explanted valve was replaced with a 21mm 8300ab valve.The patient status was reported as 'recovered'.Per the reported information, the surgery was completed with no issue confirmed after the device implant; however, the pvl was subsequently detected.The doctor affirmed that there was no malfunction of the device and the device did not cause or contribute to the event.No information on the specific timing of the pvl detection was provided by the surgeon.
|
Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.The root cause of this event was determined to be due to procedural related factors, including technical issues during suturing and inadequate debridement of calcification.The subject device is not available for evaluation as it was discarded.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
|