According to the journal article, "sandwich technique via a right ventricular incision for ultra-acute repair of post-infarction ventricular septal defects: a study of location of major residual leak," "the currently available bioglue does not allow reinforcement of severe damage, preventing occurrence of major leak.In this situation, we need to shift from the original sandwich to extended sandwich technique¿" the study evaluated 27 patients with post-infarction vsd with "sandwich-technique" repair via rv incision.Bioglue was only used in some patients.However, the article doesn't state how many patients or which cases bioglue was used.
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The manufacturing records could not be reviewed as a specific lot number or date of surgery is unknown.In the journal article ""sandwich technique" via a right ventricular incision for ultra-acute repair of post-infarction ventricular septal defects: a study of location of major residual leak," 27 surgical cases of post-infarction ventricular septal defect (vsd) were repaired by the sandwich technique through right ventricular (rv) incision.Gelatin-resorcinol-formaldehyde (grf) or bioglue was used to attach the felt and pericardial patches.Grf glue or bioglue was used to close the vsd in all cases except one and applied to defect, edge, and needle hole."the currently available bioglue does not allow reinforcement of severe damage, preventing occurrence of major leak.In this situation, we need to shift from the original sandwich to extended sandwich technique¿" the following additional information was provided by the surgeon: ¿2 of 27 cases used bioglue, and 1 of the 2 bioglue case was a bleeding case (85years female.Vsp and heart rupture).Leaks caused by the needle hole (cardiac apex, and this part was re-ruptured), this bleeding was not caused by bioglue.¿ investigation/findings: given the additional information provided by the surgeon, there were 2 cases out of 27 that used bioglue for vsd defect repair.Bleeding only occurred in one case where bioglue was used, with the surgeon stating that the bleeding and re-rupture was not caused by bioglue.It was also concluded that the surgical technique in treating post-infarction vsd depends on location and the condition of the native tissue.If there is severe damage of the tissue, the extended technique is recommended.Furthermore, the use of bioglue to repair ventricular septal perforation has successfully been reported in literature (labrousse 2006, higashi 2012).Per the additional information provided by the surgeon, the root cause of the residual leaks and re-rupture was not attributed to bioglue.There is no indication that the residual bleeding after the initial repair of the vsd is related to bioglue.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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