It was reported to intervascular that the cardioroot was cut in two parts and when using the distal part of the prosthesis for wrapping, the surgeon noticed the presence of debris and intra-prosthetic fragments resembling collagen with embolism risk.The wrapping was done nevertheless.Additional information received from the initial reporter indicates that the issue was noticed during a tirone david procedure when the involved fragment was opened to wrap the distal (extra-vascular) anastomosis.No defects were observed on the implanted fragment.The surgery was not delayed and no consequences were reported on the patient.Moreover, the surgeon is not a new user of cardioroot.
|
Corrected data : on block h1, type of reportable event was corrected from serious injury to malfunction.Indeed, according to the information received from the initial reporter the reported event does not meet the definition of a ¿serious injury¿ as described in the 21 cfr part 803.3.Actually, it did not result in life-threatening illness or injury or in permanent impairment of a body function or permanent damage to a body structure, or necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.(10/4248) a fragment of the involved device was returned to intervascular for examination.A visual inspection was performed by the quality assurance (qa) supervisor, the observation results are as follows: ¿collagen fragments were noticed in two different locations.Indeed, it is observed that the collagen layer has detached from the prosthesis and retracted forming aggregates of collagen.Consequently, there are areas without collagen (non-bright white spots).In this condition, the involved product would have been declared non-compliant in regard to the current list of acceptance and rejection standards applied during the quality control inspection.Considering the product was manipulated, it cannot be excluded that the collagen detachment may be due to product handling.¿.(19/4315) based on the investigation findings, no conclusion can be drawn on the exact origin of the reported collagen peel-off.The result of visual inspection indicates that the cardioroot was handled and cut by the customer.Considering the product was manipulated, it cannot be excluded that the collagen detachment may be due to product handling.Therefore, it is not possible to determine the root cause of the reported event.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.
|