|
A review of manufacturing records could not be performed as a definitive lot number was not provided by the complainant.A review of the available information was performed.According to initial reports from the distributor, "a patient who underwent a su[r]gery with the use of bioglue about three years ago has devel[o]ped pseudoaneurysm and an intervention followed." additional information was provided from the distributor and it was confirmed that the reported event is related to bioglue.However, a definitive lot number could not be identified.No further information could be obtained.The following information is unknown: what procedure was performed, the condition of the native tissue before surgery, how much bioglue was used in the procedure, whether used as an adjunct to sutures, or if the syringe was primed and de-aired.It is assumed that bioglue was being used for aortic repair.Per kitamura et al, pseudoaneurysm formation "is not a rare late complication late after repair of acute aortic dissection (mohammadi, s et al).The underlying mechanism of pseudoaneurysm formation is considered to be associated with tissue cutting due to the fragility of the dissected aortic wall at the anastomosis and from the chemical reaction to the aldehyde contained in the glue material (bingley, ja et al)." perhaps the native tissue was too damaged to be repaired and an aortic replacement with a synthetic graft should have been considered.Furthermore, while surgical glue is helpful in surgery for acute type a aortic dissection, it may also cause late pseudoaneurysm formation or valve deterioration when not used properly (kitamura et al).Dr.Fehrenbacher et al.Performed a retrospective review of 92 consecutive patients who underwent complex operation in which bioglue was used.Postoperative pseudoaneurysm formation occurred in 3.3% of the patients (fehrenbacher 2006).Weiner et al.Presented at 15th world congress of heart disease in vancouver, canada in july 2010 they identified 97consecutive patients in whom bioglue was used to reinforce thoracic aortic suture lines.During follow-up 2 patients were identified as having a pseudoaneurysm, the control group, without bioglue use, had similar incidences of pseudoaneurysm formation (weiner 2010).Ma et al.Reviewed 233 patients with a mean follow-up time of 2.4 years post-operation; a pseudoaneurysm was detected in only 1 patient (0.6%).The authors concluded, "the use of bioglue in thoracic aortic surgery was not associated with excess incidence of anastomotic pseudoaneurysm formation following surgical repair of thoracic aortic disease." (ma 2017).There is insufficient information to determine if there is an association between the use of bioglue and the pseudoaneurysm formed.Pseudoaneurysm formation is a known complication in standard surgical repair of aortic dissections.The condition of the native aortic tissue at the time of initial surgery is unknown in this case.Pre-existing conditions such as medial necrosis or other intrinsic aortic disease may have contributed to further complications.Root cause for this event is unknown.No further action required.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.
|
