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According to initial reports, "bg [bioglue] was used in the bentall procedure.It was confirmed that there were no abnormalities in preoperative echo, however, an embolus was found in the opening of the coronary postoperatively.It was found that the embolus was not thrombus by optical coherence tomography, therefore the surgeon suspected it was bg." additional information received.Indication for surgery: acute type a aortic dissection date of procedure: (b)(6) 2022.Anatomical site(s) where bioglue was applied: suture line, false lumen distal end, or false lumen proximal end? false lumen distal end and proximal suture line amount of bioglue applied per site: as needed were other materials used for reinforcement? if yes, specify which materials and where they were used.A felt was the target field dry at the time of application? yes was bioglue used as an adjunct to sutures? if yes, please provide details about suturing technique.Yes (suturing technique: unknown) was the vessel or graft clamped and depressurized prior to application of bioglue? yes was bioglue used in a contaminated or infected area? no please describe the condition/integrity of the native tissue where bioglue was applied: atherosclerosis, calcification, friable, inflammation, or other? friable date(s) of follow-up visits after the initial procedure: na date the event(s) occurred: 9/14/2022 was intervention required? if yes, please describe.Pci was performed.Date of intervention: (b)(6) 2022 were samples sent to pathology for examination? if yes, is a copy of the pathology report or slides available for review? no the product will not be returned to the manufacturer for evaluation.As no lot number was provided by the user facility, a six-month review of distribution records prior to date of surgery was performed for this user facility.The manufacturing records for potential lot numbers was reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.A review of the available information was performed.According to initial reports, "bg was used in the bentall procedure.It was confirmed that there were no abnormalities in preoperative echo, however, an embolus was found in the opening of the coronary postoperatively.It was found that the embolus was not thrombus by optical coherence tomography, therefore the surgeon suspected it was bg.The embolus was removed." additional information was received which noted that the embolus was not removed, and pci was performed.The patient was then discharged.The lot number was not provided, however, potential lot numbers for this timeframe were pulled from sap and manufacturing records were reviewed.Investigation: the following information about the reported event is unknown: if negative pressure was avoided during application and polymerization, how much and where bioglue was used, and whether the coronary arteries were protected during the procedure.It was reported that the embolus was not removed, and pci was performed.There are no tomography or histologic reports to confirm that the reported embolus was bioglue.Manufacturing records for potential lots during this timeframe have been reviewed.No deviations were found, and all lots were released per specifications.Given the limited information, we will rely on literature, specifically the article by gaspar et al which reports on the use of bioglue for the bentall procedure to seal the coronary anastomoses (1).Additionally, other literature recommends placement of catheters or flexible plastic cannula into the coronary ostia before applying the glue to prevent from accidental spillage into the lumen (2, 3).There is insufficient information available to determine a definitive root cause for the reported event.There are no histology or tomographic reports to confirm the embolus was bioglue.However, per the literature, obstruction of the coronary artery may have been caused by accidental spillage of bioglue into the coronary artery.Review of all product manufacturing found that all met specifications for release.No actions are required.Based on the available information, a definitive root cause for this event cannot be determined.Additionally, without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.The manufacturing records were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion ¿ formerly cryolife/jotec and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Artivion will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.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 artivion ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.
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