MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE - UNKNOWN CONFIGURATION; GLUE,SURGICAL,ARTERIES

Model Number BG UNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Mitral Regurgitation (1964); Myocardial Infarction (1969); 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 journal article, "fatal right ventricular infarction caused by bioglue coronary embolism" ; "the patient made a slow but steady recovery postoperatively until the sixth postoperative day, when she had an episode of chest pain associated with being cold and clammy.She was tachycardic, tachypnoeic, and hypotensive, with electrocardiography showing signs of inferior infarction.An echocardiogram showed a significant pericardial collection, right ventricular akinesia, and moderate mitral regurgitation.She underwent emergency resternotomy, which confirmed 500 ml of bloody pericardial effusion and a distended, akinetic right ventricle.She did not respond to inotropic support, and resuscitative measures were abandoned.".

Manufacturer Narrative

According to the journal article, ¿fatal right ventricular infarction caused by bioglue coronary embolism¿ ((b)(6) (b)(4)2004); a 74-year old woman had surgery for type a aortic dissection repair.¿the patient made a slow but steady recovery postoperatively until the sixth postoperative day, when she had an episode of chest pain associated with being cold and clammy.She was tachycardic, tachypneic, and hypotensive, with electrocardiography showing signs of inferior infarction.¿ the following information about the reported is unknown: if negative pressure was avoided during application and polymerization, how much bioglue was used, whether applied to a dry field, if the false lumen was overfilled, and whether the coronary arteries were protected during the procedure.Per the journal article, the proximal extent of the dissection occurred within the noncoronary sinus, with detachment of the noncoronary-right coronary commissure.Another tear was identified on the anteromedial aspect of the proximal arch adjacent to the orifice of the brachiocephalic artery.¿the aortic valve was repaired with resuspension of cusps.Bioglue was injected into the false lumen in the noncoronary sinus and around the false lumen at the level of the sinotubular junction.¿ the hemiarch was replaced and bioglue was injected into the false lumen at the arch level, the aortic layers were then sealed together.The postmortem examination showed that ¿the coronary tree revealed occlusion of the origin of the left circumflex artery caused by the bioglue with distal propagated thrombus¿.Bioglue emboli were also found within the right coronary artery and diagonal branch of the left anterior descending artery.The bioglue from the coronary arteries were compared to the freshly prepared bioglue and found to be identical in appearance.There are journal articles that recommend the placement of catheters in the coronary artery to protect it from obstruction.Bhamidipati et al states ¿similarly, a moist sponge can be used to protect the aortic valve leaflets and the coronary ostia when bioglue is being used to reconstruct a dissected aortic root.The left main coronary artery can also be protected by the gentle insertion of a red-rubber catheter to occlude the ostium¿.Raanani et al mentioned ¿it is essential to protect the ostia of the coronary arteries from accidental spillage of glue.This can be accomplished by inserting a fine flexible plastic cannula into the ostia before applying the glue¿.While the product ifu references using a catheter in the true lumen to keep the shape of the vessel for an aortic dissection procedure, it is not made clear to do the same for the coronary arteries: ¿the dissected layers of the aorta should be closely approximated by inserting a dilator, sponge, or catheter into the true lumen to preserve the natural architecture of the vessel¿.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 ((b)(6).(b)(6)2003).There is insufficient information available to determine a definitive root cause for the reported event.However, obstruction of the coronary arteries caused by bioglue tracking along a false lumen extending into the coronary artery or embolization into the coronary true lumen remains a possibility.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.

Event Description

According to the journal article, "fatal right ventricular infarction caused by bioglue coronary embolism" ; "the patient made a slow but steady recovery postoperatively until the sixth postoperative day, when she had an episode of chest pain associated with being cold and clammy.She was tachycardic, tachypnoeic, and hypotensive, with electrocardiography showing signs of inferior infarction.An echocardiogram showed a significant pericardial collection, right ventricular akinesia, and moderate mitral regurgitation.She underwent emergency resternotomy, which confirmed 500 ml of bloody pericardial effusion and a distended, akinetic right ventricle.She did not respond to inotropic support, and resuscitative measures were abandoned.".

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 10479542
• MDR Text Key: 205191194
• Report Number: 1063481-2020-00018
• 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
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/04/2020
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR