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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 of(b)(6)2017 and (b)(6)2019.(b)(6)2017 - use of photofix in the initial procedure: "a large boomerang-shaped patch of decellularized pericardium (photofix) was fashioned on the field.The patch was folded at the midpoint of boomerang angle and this fold was marked to be attached to the exposed part of the mitral sewing ring from one trigone to the other.First a large needle 4-0 prolene was used to attach the posterior part of the patch to the back of the left atrial roof using continuous 4-0 prolene.This suture started at the antero-lateral trigone and extended to the apex of the left atrial roof.The center fold of the patch was then attached to the exposed mitral valve sewing ring all the way across to the other trigone.Another 4-0 prolene suture was placed at this end of the fold and tied to the suture we brought across the fold.The new suture was then used to attach the front edge of the patch to the septal side of the left atrial root up to the apex which was left open to leave the vent in place.The anterior part of the pericardial patch was trimmed appropriately and attached to the divided edges of the original incision in the aorta through the annulus.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 valve.Pledgeted mattress sutures were placed around the annulus from the bottom side upward and organized on the suture guides.Sutures were placed through the pericardial patch area keeping these well above the attachment line of the mitral device as a new aorto-mitral curtain.These 19 sutures were then passed through the sewing ring of the 25 mm aortic valve.It was slid into place and the sutures tied securely.The device seated nicely on the annulus and the patch and the coronary ostia were clearly free above this.The aortic side of the pericardial patch suture line was continued to a point where the aorta could be closed primarily.The pulmonary artery side of the aorta was closed first with a double layer of continuous 4-0 prolene from the left side coming over to meet the confluence of the two patch suture lines coming up from the right.These were then tied securely.The vent was removed from the left atrium and the patch suture line there was completed and tied securely after evacuating air from the left atrium.A layer of bio-glue was applied around the root suture lines while keeping vents off and flow rate down." (b)(6)/2019 - 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 aortic or mitral regurgitation.Both valves, however, were actually working just fine.We found not just one but 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 one small hole in the patch between the two valves.There was a small amount of old bioglue in chunks within the pseudoaneurysm.All of this was removed to avoid embolization.
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Correction: age at the time of event, outcomes attributed to adverse event, brand name, model number, and report source.A review of the available information was performed.The surgeon described how he had to re-operate on (b)(4) 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 (b)(4) 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 surgeon 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 (b)(4) 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 (b)(4) procedures (86 commando and 52 hemi-commando procedures).A pericardial patch was used in (b)(4) of the commando procedures.Of the post-operative complications reported, reoperation for bleeding (undescribed) occurred (b)(4) of the cohort.Overall survival at 1 and 5 years was reported to be (b)(4) and (b)(4) , 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 (b)(4) 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 quantitiy applied.Reference (b)(4) for related reported event.Reference (b)(4) and(b)(4) 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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