MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-21 for BIOGLUE SURGICAL ADHESIVE BG3510-5-J manufactured by Cryolife, Inc. ? Kennesaw.
[136786944]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[136786965]
According to paper: unexpected intraoperative coronary malperfusion after primary repair of acute type a aortic dissection with surgical glue: during aortic root replacement for acute type a aortic dissection bioglue was placed in the false lumen. After removal of aortic cross-clamp, the wall motion of the entire left ventricle was severely deteriorated due to suspected impaired coronary blood flow. A cabg was performed. The authors assumed the narrowing was due to the dissection extending into the coronary artery. "when the false lumen was fixed with glue in the absence of blood flow of the true lumen, the space in the false lumen can be stabilized and results in stenosis against the blood flow of the true lumen. " additionally the following information could be found in the "comment" section of the paper. "however, when the false lumen was fixed with glue in the absence of blood flow of the true lumen, the space in the false lumen can be stabilized and results in stenosis against the blood flow of the true lumen. Our method using the surgical glue for the aortic root replacement needs to be discussed. Neri et al. [1] recommend to first trim the dissected wall of the sinus of valsalva and then attach the dissected rim of the coronary button with glue. However, the dissected rim of the coronary button is usually difficult to handle. The present case may indicate the risk of secondary stenosis due to an inattentional use of the surgical glue. It may be important to secure the lumen of the coronary arteries before the surgical glue is used for fixating the dissected wall. The insertion of bougies into the coronary lumen may be recommended at the surgical glue fixation site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00007 |
| MDR Report Key | 8358741 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-21 |
| Date of Report | 2019-07-05 |
| Date Facility Aware | 2019-02-05 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2019-02-21 |
| 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 |
| 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 SURGICAL ADHESIVE |
| Generic Name | GLUE,SURGICAL,ARTERIES |
| Product Code | MUQ |
| Date Received | 2019-02-21 |
| Model Number | BG3510-5-J |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? KENNESAW |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30155 US 30155 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-02-21 |