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 2019-03-26 for BIOGLUE SURGICAL ADHESIVE UNKNOWN manufactured by Cryolife, Inc..
[139850619]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[139850620]
According to the publication hickey, t. B. M. , et al. ? Iatrogenic embolization following cardiac intervention: postmortem analysis of 110 cases*.? Cardiovascular pathology 40 (2019): 12-18. A retrospective clinical pathologic autopsy analysis of 110 people that underwent endovascular procedures between 2010 and 2016 within 90 days of death and followed by hospital autopsy. Case of tissue embolism: "this case (no. 5) involved a (b)(6) woman with a past history of st-segment elevation myocardial infarction, resultant third-degree heart block, permanent pacemaker insertion, and two drug-eluting stents for complete occlusion of the right coronary artery 5 years previously. Due to worsening heart failure, she underwent repair of a left ventricular aneurysm and aortic valve. During the surgery, the left brachiocephalic vein was injured by in situ pacemaker wires and was repaired intraoperatively. A left mca territory infarct was identified day 1 postoperatively. Concurrently, she developed right-sided weakness, and a head ct scan confirmed a recent left mca territory infarct involving the basal ganglia, insula, and left temporal lobe. At autopsy, the left mca contained a tissue embolus confirmed by micro-scopic analysis. The embolic tissue displayed focal granulomatous inflammation to foreign suture-like material that had two appearances: eosinophilic and pale to white. These were suggestive of two different types of sutures. Fragments of eosinophilic material consistent with bioglue surgical adhesive were also identified. Detailed examination of the heart showed a left ventricle aneurysm repair site mural thrombus admixed with bioglue and suture material, the likely source of the left mca embolus. " the patient died 15 days later following the endovascular procedure from the extensive left middle cerebral artery stroke. Cardiac tissue embolized to the left m1 mca artery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00013 |
| MDR Report Key | 8451962 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-26 |
| Date of Report | 2019-06-03 |
| Date Facility Aware | 2019-03-19 |
| Date Mfgr Received | 2019-03-19 |
| Date Added to Maude | 2019-03-26 |
| 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 | 2019-03-26 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 | 2019-03-26 |