Manufacturer narrative: (b)(4).Type of investigation: trend analysis - review of similar complaints for all gelsoft plus / gelsoft devices and leakage gave an occurrence rate of (b)(4).Type of investigation: communication/interviews - information received from site indicated that the device was not pre-soaked prior to procedure contrary to ifu warnings and precautions which state "the prosthesis must be immersed in a sterile saline solution for 5 minutes.Failure to rinse for 5 minutes could lead to the graft being more susceptible to leakage when implanted" type of investigation: analysis of production records - review of qc and manufacturing records with attention to all in process and base material porosity tests showed batch was manufactured to design specification and all porosity testing on gelled product and base material met acceptance criteria.Type of investigation - 4114 - device not returned - device remains implanted and was not returned for further investigation.Investigation findings: no device problem found - no issue was found with manufacture of the batch on review of production records investigation conclusion: caused traced to user - information received from site indicated that the device was not pre-soaked prior to use as recommended in ifu to improve device handling.This may have been a contributory cause of the leakage seen.Investigation conclusions: failure to follow instructions - user did not follow instructions in ifu regarding pre-soak of device.Vascutek ltd.Now considers this complaint closed.Further action is not planned, however, the issue will be tracked, and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
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Event reported from maastricht umc+, netherlands as follows: "no relevant medical history.Patient came with symptomatic aaa.No antiplatelet.5000u heparin clamping aorta, proximal anastomosis.Clamping direct under proximal anastomosis, making distal anastomosis.After releasing the clamp, 3 small holes in mid segment of graft.1 hole is sutured, other 2 holes closed by manual compression.The event had no consequences for post-operative treatment.".
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