MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-09-06 for BIOGLUE - UNKNOWN CONFIGURATION BG UNK manufactured by Cryolife, Inc..
[119413197]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[119413198]
According to the initial report, patient died during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[128618990]
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 made. A (b)(6) man was admitted on (b)(6) 2018 for severe middle back pain. A ct angio of the chest and abdomen confirmed a type 1 dissection starting at the aortic valve and extending through the ascending aorta into the transverse aorta. An emergent bentall procedure was performed. During the surgery, bioglue was then applied along the annulus, left main coronary button, and right coronary artery button. "the distal aorta had false lumen filled with bioglue followed by creation of a dual sandwich felt when inside and when outside the aorta. " the repair was finished and the patient was weaned from cardiopulmonary bypass. Operative notes state: "initially the bleeding appeared to be ceasing and there was good cardiac rhythm. Then bleeding became apparent somewhere posteriorly at the proximal anastomosis area. Multiple sutures were applied unsuccessfully to try and stop the bleeding. Patient developed bradycardia and pea continued efforts with volume resuscitation, inotropic support and further attempts to abort bleeding were unsuccessful. Patient was pronounced dead. " there is no evidence in the operative notes which indicate what contribution, if any bioglue had to the death. The operative notes do not indicate the bleeding at the proximal anastomosis was due to a 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 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 anastomotic sealing showing no difference in rates of death between the bioglue and control groups (coselli et al. 2003). The root cause of the bleeding event is unknown; the patient expired during the repair effort. There is no evidence which indicates what contribution if any bioglue had to the death. No further action required.
Patient Sequence No: 1, Text Type: N, H10
[128618991]
According to the initial report, patient died during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00036 |
| MDR Report Key | 7852174 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-09-06 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-07-31 |
| Date Facility Aware | 2018-08-17 |
| Date Mfgr Received | 2018-08-17 |
| Date Added to Maude | 2018-09-06 |
| 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 | 2018-09-06 |
| Model Number | BG UNK |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-09-06 |