This is the second case reported by this surgeon regarding a mass forming after the use of bioglue at the dura suture site to prevent csf leak after surgery.This case reports persistent left pain after decompression.The following information is unknown: how much bioglue was used, how it was applied (drops, thin layer, etc.), information surrounding the circumstances of the bioglue application (priming, etc.), and how much time had passed before the mass was discovered.There is no photo of the mass for this case, nor information regarding how the surgeon determined that it contained bioglue.In the 2014 journal article written by miscusi et al regarding bioglue being used to reinforce a dural repair site, the authors state "it is essential that a very thin layer of bioglue is applied; the application of larger quantities may create a pooling of glue, potentially leading to serious side effects, such as compression of the spinal cord and nerve roots (woo ej 2012)".The authors also conclude, "in all our patients, in both cranial and spinal surgery, we have never experienced complications directly related to its use".They found bioglue to be effective in intraoperative dural tears repair without resulting complications (miscusi et al 2014).Based on the available information, a definitive cause cannot be determined.Additionally, it is unknown how the bioglue was applied and if a thin layer was used.The pooling of bioglue creating a mass lesion resulting in neuro compression remains a possibility.The instructions for use warning states that "polymerized bioglue has occupying properties.When used improperly, or applied incorrectly, serious adverse events have been reported relating to compression of adjacent anatomic structures".This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
|