MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-06-05 for LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION UNK manufactured by Pluromed Inc..
[3629029]
Ventricular fibrillation [ventilator fibrillation]. Undissolved legoo remaining in vessel [product solubility abnormal]. Case description: spontaneous report was received on (b)(6) 2013 from a physician regarding a (b)(6) male pt, initials unk. The pt's medical history was not provided. On an unspecified date, the pt received legoo (endovascular occlusion gel) injection, dosage regimen not provided, during off-pump cabg (coronary artery bypass grafting). The lot number for legoo was not provided. It was reported that legoo was used to occlude 3 vessels and was dissolved using cold saline successfully each time. The same day (on an unk date), the pt experienced the life-threatening event of ventricular fibrillation at the end of the off pump cabg (coronary artery bypass grafting) case. It was reported by the physician that there could have been a possibility of an air embolism causing ventricular fibrillation due to some undissolved legoo remaining in the vessel (product dissolution abnormal) which caused an air pocket when it dissolved after the anastomosis was complete. On an unspecified date, the event of ventricular fibrillation resolved. The outcome for the event of "undissolved legoo remaining in the vessel was not provided. Relevant concomitant medications were not provided. The intensity for the event of ventricular fibrillation was severe. The intensity for the event of "undissolved legoo remaining in the vessel" was not provided. The causal relationship between legoo and the events was not provided by the reporting physician.
Patient Sequence No: 1, Text Type: D, B5
[10951623]
Mfr's comment: as only limited info has been obtained so far, it is difficult to assess a cause and effect relationship.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008867907-2013-00004 |
| MDR Report Key | 3202310 |
| Report Source | 05,07 |
| Date Received | 2013-06-05 |
| Date of Report | 2013-05-30 |
| Date Mfgr Received | 2013-05-30 |
| Date Added to Maude | 2013-07-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRUNO MENDEZ |
| Manufacturer Street | 675 WEST KENDALL STREET |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| Manufacturer G1 | PLUROMED INC. |
| Manufacturer Street | 175 NEW BOSTON ST SUITE F |
| Manufacturer City | WOBURN MA 01801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION |
| Generic Name | ENDOVASCULAR OCCLUSION GEL |
| Product Code | OBC |
| Date Received | 2013-06-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLUROMED INC. |
| Manufacturer Address | WOBURN MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2013-06-05 |