MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW BIOGLUE SYRINGE 5-PACK, 10 ML,JAPAN; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5-J

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death (1802); Neurological Deficit/Dysfunction (1982); Rupture (2208); Aortic Dissection (2491); Pseudoaneurysm (2605); No Code Available (3191)

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 the initial report received, "a retrospective, single center study of 544 patients that underwent treatment for acute type a aortic dissection (aaad) repair.Bioglue was applied to the false lumen to adhere dissected layers of the proximal aortic stump in all patients.The average age of patients was 68.6 +/- 12.2 years with 47% male patients and 53% female.The median follow-up period was 3.1 years (interquartile range, 1.3 to 4.8 years).Post-operative data includes: intubation time of 18 hours (13-28 hours), icu stay of 2 days (1-2 days), re-exploration for bleeding in 31 (5.7%) of patients, permanent neurological deficit in 56 (10.3%), temporary dialysis in 34 (6.3%), and operative mortality rate of 4.6%.At 5 years post-surgery, cumulative survival rate was 79.5%.Aortic root reintervention was performed in 11 patients (0.6/100 patient-year), with the time interval for reintervention ranging from 0 to 46 months.The aortic complications of the 11 patients included: pseudoaneurysm (n = 5), redissection (n = 3), ruptured pseudoaneurysm (n = 2), and root rupture (n = 1).Aortic root reintervention was rare among patients that underwent aaad repair using bioglue.With aortic root redissection occurring in the early phase compared to pseudoaneurysm formation, care should be taken to confirm the secure gluing of the false lumen at time of surgery.".

Manufacturer Narrative

Clinical / medical reviewed the available information.Dr.Fehrenbacher et al.Performed a retrospective review of 92 consecutive patients who underwent complex operation in which bioglue was used.Postoperative pseudoaneurysm formation occurred in 3.3% of the patients (fehrenbacher 2006).Weiner et al.Presented at 15th world congress of heart disease in vancouver, canada in july 2010 they identified 97 consecutive patients in whom bioglue was used to reinforce thoracic aortic suture lines.During follow-up 2 patients were identified as having a pseudoaneurysm, the control group, without bioglue use, had similar incidences of pseudoaneurysm formation (weiner 2010).Ma et al.Reviewed 233 patients with a mean follow-up time of 2.4 years post-operation; a pseudoaneurysm was detected in only 1 patient (0.6%).The authors concluded, ¿the use of bioglue in thoracic aortic surgery was not associated with excess incidence of anastomotic pseudoaneurysm formation following surgical repair of thoracic aortic disease.¿ (ma 2017).Furthermore, death is a potential adverse event related to cardiac and vascular procedures.In 1998 cryolife began a clinical trial investigating the use of bioglue as an adjunct in the surgical repair of acute, stanford type a aortic dissections.A total of 175 patients were enrolled in this study.This included 54 non-randomized (lead-in) patients, 60 patients randomized to standard surgery plus bioglue, and 61 patients randomized to standard surgery only.An interim analysis was performed after the 100th patient was enrolled into the randomized portion of the trial and had completed the 30-day follow-up period.There was no statistically significant difference in early mortality between the two groups (bioglue summary of safety and effectiveness).A prospective randomized control trial between bioglue and standard surgical repair for anastamotic sealing showed no difference in rates of death between the bioglue and control groups (coselli et al.2003).There is no evidence to suggest that bioglue contributed to any of the reported adverse events within the publication.These reported events are common complications of aortic dissection surgery.There is also insufficient information to determine if there is an association between the use of bioglue and the pseudoaneurysms formed in the procedures.Pseudoaneurysm formation is a known complication in standard surgical repair of aortic dissections.The condition of the native aortic tissue at the time of initial surgery is unknown in this case.Pre-existing conditions such as aortic medial necrosis or other intrinsic aortic disease may have contributed to further complications.Risk management reviewed the available information.There is no evidence to suggest that bioglue contributed to any of the reported adverse events within the publication.These reported events are common complications of aortic dissection surgery.There is also insufficient information to determine if there is an association between the use of bioglue and the pseudoaneurysms formed in the procedures.Pseudoaneurysm formation is a known complication in standard surgical repair of aortic dissections.The condition of the native aortic tissue at the time of initial surgery is unknown in this case.Pre-existing conditions such as aortic medial necrosis or other intrinsic aortic disease may have contributed to further complications.The reported event will continue to be monitored for trends.No updates to the rmf are needed in response to this complaint.Risk has been reduced as low as possible and overall residual risk is acceptable.A potential root cause cannot be established as there is no evidence to suggest that bioglue contributed to any of the reported adverse events within the publication.These reported events are common complications of aortic dissection surgery.Adequate precautions regarding risk are provided in the ifu.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.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.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML,JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10574754
• MDR Text Key: 208170610
• Report Number: 1063481-2020-00021
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other; Disability