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The surgeon described how he went back in after commando surgery and saw holes in photofix.He believes that solidified bioglue rubbing against photofix caused holes in photofix.The remaining areas of photofix seemed fine.Patient surgery dates on (b)(6) 2016 and on (b)(6) 2018.On (b)(6) 2016: use of photofix in the initial procedure: "a large boomerang-shaped patch of bovine pericardium (photofix) was prepared on the table.The patch was folded at the midpoint of boomerang angle and the posterior corner of this fold was first attached to the exposed part of the mitral sewing ring under the old posterior aortic commissure.From there, the shorter triangular part of the patch was attached to the left side of the left atrial roof from the posterior trigone to the top corner using continuous 4-0 prolene.The patch was folded to the back and the 2 cm wide folded edge in the middle was attached to the exposed part of the mitral device across to the front side.The other side of the roof portion of the patch was then attached to the atrial wall including the atrial septum in the process.A pledgeted suture had been placed loosely at the apex of the roof incision to allow us to keep our vent there until later.The suture lines were brought to either side of this point to tie together later.Another 4-0 prolene suture was placed at each end of the fold and brought through the aortic wall and tied securely.These two sutures were then used to attach the longer aortic end of the patch to either side of the aorta where it had been split down to the mitral taking care to get the corners tight.These sutures were brought up about 1.5 cm above the anticipated new aortic annulus and secured.The expanded aortic annulus was measured again, and we chose the 25 mm valve.We marked the level long the patch where the sutures should go according to the position of the sizer as we measured it.This allowed the last four aortic sutures to be placed across the patch with a transitional suture at each end including native annulus and patch.Pledgeted mattress sutures were placed around the aortic annulus from the bottom up and organized on the suture guides.Great care was taken to stay very low under the left main which was closer to the annulus than the right.The 16 aortic sutures were then passed through the sewing ring of the 25 mm aortic valve.It was easily slid into place and the sutures tied securely.The device seated very nicely on the annulus and the patch and the coronary ostia were seen to be free well above this.The left atrial vent was removed and the pledgeted suture at that end of the roof was tied securely as well as the two ends of the roof patch continuous suture lines.The vent was placed through the aortic valve into the lv at this point.The aortotomy was then closed with a double layer of continuous 4-0 prolene starting from the pulmonary artery side to about the middle of the front.The aortic side of the pericardial patch suture line was then continued to the point of the patch and then on over to meet the sutures from the left side to which they were tied securely.A dose of bio-glue was applied to the root and patch area after drying up the surfaces thoroughly." on (b)(6) 2018: re-op notes: an operation tee confirmed the expected findings of high-volume fistula flowing from the aorta into the left atrium that behaved hemodynamically like severe mitral regurgitation.Both valves, however, were actually working just fine.Surgeon found two large holes in the aortic side of the patch material and at least two more on the left atrial side but no obvious sign of infection.There was a moderate amount of old bioglue in chunks within the pseudoaneurysm.All of this was removed to avoid embolization.
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A review of the available information was performed.The surgeon described how he had to re-operate on 2 patients that had undergone a commando surgery where in photofix was implanted as part of the surgical reconstruction.The reoperations were done to repair holes in the photofix.The surgeon described details of the incident operations both of which were in elderly patients with prior cardiac reconstruction and complex cardiac histories.Both reoperations were to repair holes in the photofix and both occurred approximately 2 years post-operative from the original reconstruction.The abraded photofix was removed and was replaced in both re-operations.This complex procedure includes the use of many different and varied medical devices (valves, suture, pledgets, hemostatic agents or protein hydrogels).The urgeon indicated that bioglue was used, potentially in a ¿too generous¿ application during the incident operations.Additionally, the application of the patch material is within a very tight space in the cardiac cavity, specifically forming the left atrial wall and the aortic wall.He commented that this is a region of continuous movement and indicated that there were areas of friction and that this mechanical component is what lead to eroding and weakening areas of the photofix.Holes were only seen in some areas and the rest of the remaining photofix was fine.He has been performing this procedure for over a decade and these are the only 2 cases (of approximately 65) with this observed outcome.The ¿commando procedure¿ is a used for the surgical management of invasive double-valve infective endocarditis involving the intervalvular fibrosa and is technically challenging and complex cardiac reconstruction.There is small body of literature reporting on techniques and/or clinical outcomes.The use of autologous leaflet, bovine pericardial patch or synthetic material are all described in the literature.Type of patch chosen is generally on availability of suitable autologous pericardium followed by surgeon preference: photofix, glutaraldehyde-fixed bovine pericardium or synthetic material.Navia, et al., recently reported on their series of 138 procedures (86 commando and 52 hemi-commando procedures).A pericardial patch was used in 74% of the commando procedures.Of the post-operative complications reported, reoperation for bleeding (undescribed) occurred 16% of the cohort.Overall survival at 1 and 5 years was reported to be 67% and 48%, respectively.The photofix manufacturing process includes 100% visual inspection prior to final packaging.No tissue samples were returned for evaluation.The use of pericardial patch is well established surgical adjunct used during this procedure.Per the discussion with the surgeon and the complexity of the surgical application of the photofix, it is feasible the source of the holes was attributed to the mechanical friction between the patch juxtapositions to each other and or other devices used during the procedure.Normal cardiac rhythm and motion over the 2 post-operative years in conjunction with the anatomically confined space may likely have contributed to the erosion of the photofix leading to the reported holes.Although this specific event was not reported in the navia publication, comparatively, both of these patients had 100% survival at 2+ years post-operative.The bioglue ifu it warns ¿bioglue should be applied in a thin layer as an adjunct to sutures or staples, and in amounts sufficient to seal the area.Bioglue should not be applied in excess.¿ bioglue degrades via proteolysis and can be slow to resorb dependent on the quantity applied.Reference 1063481-2019-00062 for related reported event.Reference 1063481-2019-00060 and 1063481-2019-00059 for similar reported event.No further action recommended.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.
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