|
Model Number BG3510-5-J |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Intimal Dissection (1333); Hematoma (1884)
|
Event Date 10/29/2013 |
Event Type
Death
|
Manufacturer Narrative
|
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
|
|
Event Description
|
According to article "redissection of the aortic root three months after replacement of the ascending aorta for acute stanford type a dissection: report of a case" by takeshi someya, et al."we report a case of redissection of the aortic root after graft replacement for acute aortic dissection using bioglue to approximate the false lumen.A (b)(6) man underwent graft replacement of the ascending aorta for acute aortic dissection.In this operation, bioglue was applied to the false lumen of the aortic root.Three months later, computed tomography revealed an ulcer-like projection and an intramural hematoma in the aortic root.Aortic root replacement was performed, in which operative findings showed a new intimal tear and a patent false lumen contained with hematomas and a fragment of bioglue.Histological examination showed no evidence of adhesion between the intimal media and the adventitia of the aorta, or toxic effect of bioglue.We conclude that care should be taken in applying the bioglue to a false lumen and that cautious follow-up is mandatory not to overlook redissection." additionally, the following information was obtained: current status of the patient - dead about 1 year later of 2nd surgery due to unknown reason date of initial surgery - (b)(6) 2013 date of reintervention - (b)(6) 2013 amount of bioglue - i do not remember the amount precisely, but i assume that the amount was more than recommended.Product code / lot number of product - i am sorry that i do not have any idea.
|
|
Manufacturer Narrative
|
As a definitive lot number was not provided, the distributor provided possible lot numbers shipped to the hospital in the 6 months prior to the date of implant.The manufacturing records were reviewed for the material components used for the processing of lots 12mjx024, 13mjx001, 13mjx002, 13mjx003, 13mjx011, 13mjx012.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 was performed of the available information.A case report titled, ¿redissection of the aortic root three months after replacement of the ascending aorta for acute stanford type a dissection: report of a case¿ by takeshi someya et al.The patient was a (b)(6) man who on (b)(6) 2013 underwent a graft replacement of the ascending aorta for acute aortic dissection where bioglue was applied to the false lumen of the aortic root.The surgeon stated that he did not remember the precise amount of bioglue use, ¿i assume that the amount was more than recommended.¿ an ¿ulcer-like projection and an intramural hematoma in the aortic root¿ was identified by computed tomography three months post-op.On (b)(6) 2013 an aortic root replacement was performed.The re-operation showed a new intimal tear and a patient false lumen contained hematomas and a fragment of bioglue.No evidence of adhesion between the intimal media and the adventia of the aorta, or toxic effect of bioglue was noted during histological examination.The paper concluded that ¿care should be taken in applying bioglue to a false lumen and cautious follow-up is mandatory not to overlook redissection.¿ additional information was received from the surgeon that the patient died approximately one year after the reoperation due to unknown reasons.The case report states that the histologically the tissue toxicity findings, as those found in cases where gelatin-resorcinol-formaldehyde (grf) glue is used, were not seen during this case where bioglue was used and that chemical damage due to glutaraldehyde is unlikely.The case report concludes, ¿in our opinion, bioglue must be used appropriately during operations, proper stitching must be performed, and it is also necessary to carefully monitor patients, even if there are no evident problems upon discharge.¿ it is unknown what effect if any the ¿assumed more than recommended¿ amount used during the initial operation had on the reported event.There is also no information that would relate bioglue to the patient¿s death approximately a year after reoperation.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 suspension, tar+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 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.No further action required.
|
|
Event Description
|
According to article "redissection of the aortic root three months after replacement of the ascending aorta for acute stanford type a dissection: report of a case" by takeshi someya, et al."we report a case of redissection of the aortic root after graft replacement for acute aortic dissection using bioglue to approximate the false lumen.A (b)(6) man underwent graft replacement of the ascending aorta for acute aortic dissection.In this operation, bioglue was applied to the false lumen of the aortic root.Three months later, computed tomography revealed an ulcer-like projection and an intramural hematoma in the aortic root.Aortic root replacement was performed, in which operative findings showed a new intimal tear and a patent false lumen contained with hematomas and a fragment of bioglue.Histological examination showed no evidence of adhesion between the intimal media and the adventitia of the aorta, or toxic effect of bioglue.We conclude that care should be taken in applying the bioglue to a false lumen and that cautious follow-up is mandatory not to overlook redissection." additionally, the following information was obtained: current status of the patient - dead about 1 year later of 2nd surgery due to unknown reason date of initial surgery - (b)(6) 2013 date of reintervention - (b)(6) 2013 amount of bioglue - i do not remember the amount precisely, but i assume that the amount was more than recommended.Product code / lot number of product - i am sorry that i do not have any idea.
|
|
Search Alerts/Recalls
|
|
|