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According to the report received from the surgeon, the patient underwent an ascending aorta replacement on (b)(6) 2011 where bioglue was used on the proximal and distal anastomoses.The patient underwent a reoperative surgery on (b)(6) 2017 where bioglue was identified intraoperatively.The following visual observations were noted: bioglue "was applied between aortic layers in both proximal and distal anastomosis in exceeding quantity." tissue "lack of elasticity and focal sign of necrosis." suture, pledgets, etc."teflon layers inside and outside native aorta." samples were sent to pathological assessment.No residual bioglue or thrombus was identified in the distal anastomosis.Residual bioglue with associated dense lymphoplasmacytic inflammatory infiltrate and foreign body type giant cell reaction in adjacent aortic media was identified in the proximal anastomosis.Patient's medical history includes hypertension and previous smoker.
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Additional information received 05/04/2017: possible lot numbers shipped to the hospital in the 6 months prior to implant: 11mgv047, 11mgv081, 11mgv098. all three lots will be investigated. this investigation is currently ongoing. any additional information will be provided in the follow-up report.
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According to the report received from the surgeon, the patient underwent an ascending aorta replacement on (b)(6) 2011 where bioglue was used on the proximal and distal anastomoses.The patient underwent a reoperative surgery on (b)(6) 2017 where bioglue was identified intraoperatively.The following visual observations were noted: bioglue "was applied between aortic layers in both proximal and distal anastomosis in exceeding quantity." tissue "lack of elasticity and focal sign of necrosis." suture, pledgets, etc."teflon layers inside and outside native aorta." samples were sent to pathological assessment.No residual bioglue or thrombus was identified in the distal anastomosis.Residual bioglue with associated dense lymphoplasmacytic inflammatory infiltrate and foreign body type giant cell reaction in adjacent aortic media was identified in the proximal anastomosis.Patient's medical history includes hypertension and previous smoker.
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According to the report received from the surgeon, the patient underwent an ascending aorta replacement on (b)(6) 2011 where bioglue was used on the proximal and distal anastomoses.The patient underwent a reoperative surgery on (b)(6) 2017 where bioglue was identified intraoperatively.The following visual observations were noted: bioglue "was applied between aortic layers in both proximal and distal anastomosis in exceeding quantity." tissue "lack of elasticity and focal sign of necrosis." suture, pledgets, etc."teflon layers inside and outside native aorta." samples were sent to pathological assessment.No residual bioglue or thrombus was identified in the distal anastomosis.Residual bioglue with associated dense lymphoplasmacytic inflammatory infiltrate and foreign body type giant cell reaction in adjacent aortic media was identified in the proximal anastomosis.Patient's medical history includes hypertension and previous smoker.
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Manufacturing records of the bioglue lot numbers 11mgv047, 11mgv081, and 11mgv098 were reviewed.It was confirmed that all records were controlled, available for review, and met all specifications.Patholigical review of returned tissued determined the following: gross description- specimen 1 is identified as distal anastomosis.It consists of an opened tubular-shaped structure consisting of a 3.0 cm segment of synthetic vascular graft anastomosed to a ring of residual aortic tissue.The aortic portion measures 2.2 cm in diameter when re-approximated and consists of approximately 5 mm of aortic length.The suture line of the anastomosis appears intact with pannus overgrowth along the intimal surface (image 1).The aortic margin consists of two layers suggestive previous dissection; however, no thrombus or bioglue is observed between the layers (image 2).The adventitial surface of the anastomosis shows dense fibrous tissue mixed with fat.No overt pseudoaneurysm or bioglue is noted on the adventitial surface.Representative sections of the anastomosis are submitted circumferentially in cassettes 1a-1i.Specimen 2 is identified as proximal anastomosis, noncoronary sinus.It consists of a segmental resection of a well- healed anastomotic site containing a 2.0 x 0.6 cm portion of residual aortic tissue with adjacent 2.0 x 1.5 cm segment of synthetic graft material.The suture line appears intact with pannus overgrowth on the luminal surface.The adventitial surface shows fibrous connective tissue with no apparent hemorrhage.At the tissue margin a 0.6 cm portion of firm amber material grossly consistent with bioglue is present between layers of aortic media (image 3).There is no grossly identifiable reaction or hemorrhage surrounding the bioglue.The specimen is serially sectioned and submitted entirely in cassettes 2a through 2d.Microscopic description- sections of the distal anastomosis show a well-healed surgical anastomosis between native aortic tissue and synthetic graft material.Teflon pledget material is on either side of residual aorta media and is surrounded by a moderate foreign body type giant cell reaction.The residual aorta shows fibrosis and mild focal generative changes with sparse chronic inflammation.There is separation of the layers of the remaining aortic media, consistent with the two layers noted at the aortic margin grossly, possibly representing a residual remote false lumen.No residual bioglue or thrombus is noted within this space.Sections of the proximal anastomosis show a well-healed surgical anastomosis of aorta to adjacent synthetic vascular graft material.Homogenous eosinophilic material consistent with bioglue is immediately adjacent to residual aortic media (image 4) there is a focal dense lymphoplasmacytic inflammatory infiltrate with a foreign body type multinucleated giant cell reaction in the aortic wall adjacent to the bioglue.Interestingly, the inflammatory process stops abruptly at the point in which bioglue resumes tight contact with the media (image 5).Scattered lymphocytes and plasma cells can also be found throughout the remaining thickness of the aortic wall.There is disruption of the architecture of the media with absence of nuclei within the fibroblast and smooth muscle cells.Degenerative changes of the media and calcification is also noted adjacent to a suture hole.The aortic media, where it remains immediately attached to bioglue, does retain nucleated cells in the layers adjacent to bioglue, however the deeper layers of the media appear acellular and degenerative (image).Final diagnosis- distal anastomosis.Well-healed, intact surgical anastomosis with fibrosis.Aorta with mild focal degenerative changes and possible residual false lumen at margin.No residual bioglue or thrombus identified.Minimal chronic inflammation.Foreign body type inflammatory reaction to teflon felt and graft material.Proximal anastomosis.Well-healed, intact surgical anastomosis with fibrosis.Residual bioglue with associated dense lymphoplasmacytic inflammatory infiltrate and foreign body type giant cell reaction in adjacent aortic media.Degenerative changes of the aorta.Foreign body giant cell inflammatory reaction to teflon felt and graft material.A review of the available information was performed.Subject (b)(6) in the study titled ¿clinical observation and pathological characterization of aortic tissue at reoperation¿ underwent a frozen elephant trunk and modified bentall due to a type a aortic dissection approximately 5 years after an ascending aorta replacement procedure in which bioglue was used.At the time of reoperation, the tissue was described as lack of elasticity and focal sign of necrosis.Tissue samples from the reoperation were provided and examined pathologically.The excised tissue at the distal anastomosis shows a well-healed, intact surgical anastomosis with fibrosis, no residual bioglue or thrombus identified, and minimal chronic inflammation.The excised tissue at the proximal anastomosis shows a well-healed intact surgical anastomosis with fibrosis, residual bioglue with associated dense lymphoplasmacytic inflammatory infiltrate and foreign body type giant cell reaction in adjacent aortic media and there is no grossly identifiable reaction or hemorrhage surrounding the bioglue.There was no sign of suture rupture at either anastomosis.Remnant false lumen was noted in the native aorta at both the native and distal margins.It is noted in the case report form that an ¿exceeding quantity¿ use of the product at the initial surgery with subsequent absence of complete absorption at the proximal anastomosis however, it is unknown if this contributed to the dissection which occurred approximately 5 years after the initial operation.In the case report forms, the surgeon did not allege a deficiency in bioglue associated with the pathologic findings seen at surgery.Histopathology of the returned tissue shows inflammation surrounding the residual bioglue however, no overt necrosis of aortic tissue was noted.There were histologic signs of medial degeneration of native aortic tissue in areas without residual bioglue.This finding suggests that aortic degeneration is likely related to the patients underlying aortic disease and not the residual bioglue.Re-dissection after aortic dissection repair has been reported in literature though not commonly.Kazui et al.Reported re-dissection of the aortic root in one patient 5 months after initial surgery of av (aortic valve) suspension, tar (total arch replacement) +elephant trunk in which bioglue was used (kazui et al 2001).Raanani et al.Looked at the time the newly developed bioglue vs the commonly used grf (gelatin-resorcinol-formaldehyde) glue paying special attention to re-dissection rates.The authors used bioglue in 22 patients with acute type a aortic dissection, during follow-up (16 months) none of the patients required reoperation for re-dissection (raanani et al.2004).The root cause of the reported event cannot be determined.The pathologic and clinical findings are most likely related to the patient¿s underlying disease process.The instructions for use lists local tissue necrosis as a potential adverse event that may occur with the use of bioglue.This event does not identify additional hazards or modify the probability and severity of existing hazards.
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