It was reported to intervascular from the health facility that a porosity issue with the prosthesis occurred.They reported an ¿extreme porosity of the prosthetic left leg¿.The right leg was waterproof.It was decided to keep the prosthesis implanted because the proximal anastomosis had already been performed on the aorta.This is the first time this center encountered this issue.They associated this event with a potential risk of hemorrhage, a potential increase in the duration of the operation if the surgeon had to explant the graft and finally, increased risks on a fragile patient.
|
Corrected data : on block h1, type of reportable event was corrected from serious injury to malfunction.Indeed, no additional information has been received from the initial reporter as of the date of this report, thus considering the event description initially reported, there is no evidence that the reported event meets the definition of a ¿serious injury¿ as defined in regulation.There was no indication that the situation was life threatening, caused permanent damage to the body function or permanent damage to the body structure nor necessitated medical or surgical measures to avoid permanent injury or impairment.(4111/3221) no additional information about the incident was obtained in spite of several attempts to contact the surgeon.In view of the lack of information from initial reporter, no further investigation can be performed (67) no conclusion can be drawn on the exact origin of reported event since the product remained implanted.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.
|