MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-17 for BIOGLUE - UNKNOWN CONFIGURATION BG UNK manufactured by Cryolife, Inc..
[120457321]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[120457322]
According to the initial report, patient died during the procedure. It was found from the operative notes received that bioglue was used during the procedure. The operative notes indicate that the patient presented with chest pain and was diagnosed with ascending aortic dissection. Preoperatively, the patient was neurologically intact and had adequate pressures. Chest ct revealed ascending aortic dissection which began at the aortic valve, extended into the arch involving carotid vessels and down into the thoracic aorta to just below the renal arteries. Findings included approximately 400ml of blood in the pericardial sac with clot. Dissection involved the right coronary artery which was avulsed from the avulsed from the ascending aorta and appeared to be the source of the intrapericardial bleed. Following replacement aortic valve seating, bioglue was applied. The patient was weaned from cardiopulmonary bypass. Initially, there was poor contractility of the right heart, so the patient was placed back on cardiopulmonary bypass. The patient gained reasonable but not good contractility of the right heart. The patient's right heart continued to fail with progressively more hypotension. Medications and intracardiac massage were given. Right heart was never able to get into a functional state and the patient was pronounced dead.
Patient Sequence No: 1, Text Type: D, B5
[130061412]
Attempts to obtain the lot number were made with no success; therefore, manufacturing records could not be obtained. A review of the available information was performed. The patient was a (b)(6) woman who was diagnosed with ascending aortic dissection. A chest ct scan? Revealed ascending aortic dissection which began at the aortic valve, extended into the arch involving carotid vessels and down into the thoracic aorta to just below the renal arteries.? It was recommended she undergo emergency surgery for hopeful salvage. Findings included approximately 400ml of blood in the pericardial sac with clot. ? Dissection involved the right coronary artery which was avulsed from the ascending aorta and appeared to be the source of the intrapericardial bleeding.? Bioglue was applied following the replacement of the aortic valve seating. The patient was then weaned from the cardiopulmonary bypass where initially there was poor contractility of the right heart. The patient was then placed back on the cardiopulmonary bypass. The patient? S right heart continued to fail with more progressively hypotension; medications and intracardiac massage were given. The patient? S? Right heart was never able to get into a functional state and the patient was pronounced dead.? There is no evidence in the operative notes which indicate what contribution, if any bioglue had to do with the death. The operative notes do not indicate that the failure of the right heart was due to the use or failure of bioglue. 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 the death of the patient.
Patient Sequence No: 1, Text Type: N, H10
[130061413]
According to the initial report, patient died during the procedure. It was found from the operative notes received that bioglue was used during the procedure. The operative notes indicate that the patient presented with chest pain and was diagnosed with ascending aortic dissection. Preoperatively, the patient was neurologically intact and had adequate pressures. Chest ct revealed ascending aortic dissection which began at the aortic valve, extended into the arch involving carotid vessels and down into the thoracic aorta to just below the renal arteries. Findings included approximately 400ml of blood in the pericardial sac with clot. Dissection involved the right coronary artery which was avulsed from the avulsed from the ascending aorta and appeared to be the source of the intrapericardial bleed. Following replacement aortic valve seating, bioglue was applied. The patient was weaned from cardiopulmonary bypass. Initially, there was poor contractility of the right heart, so the patient was placed back on cardiopulmonary bypass. The patient gained reasonable but not good contractility of the right heart. The patient's right heart continued to fail with progressively more hypotension. Medications and intracardiac massage were given. Right heart was never able to get into a functional state and the patient was pronounced dead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00037 |
| MDR Report Key | 7882409 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-17 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-08-06 |
| Date Facility Aware | 2018-08-21 |
| Date Mfgr Received | 2018-08-21 |
| Date Added to Maude | 2018-09-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOGLUE - UNKNOWN CONFIGURATION |
| Generic Name | GLUE,SURGICAL,ARTERIES |
| Product Code | MUQ |
| Date Received | 2018-09-17 |
| Model Number | BG UNK |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-09-17 |