MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-06-14 for LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION UNK manufactured by Pluromed Inc..
[18055733]
Continued to block the vessel [vascular occlusion]. Legoo plug migrated down the vessel [product solubility abnormal]. Case description: spontaneous report was received on (b)(4) 2013 from a surgeon via a sales representative regarding a patient (demographics not provided), initials unknown. The patient's medical history was not provided. On (b)(6) 2013, legoo (endovascular occlusion gel) was injected (dosage regimen not provided) in an unspecified vessel during a peripheral vascular bypass surgery on leg, for vascular occlusion. The lot number for legoo was not provided. It was reported that "legoo plug migrated down the vessel" and "continued block the vessel" even after anastomosis was finished being reconnected. The blockage occurred on distal side of anastomosis. The surgeon did flush the vessel with saline after the bypass and confirmed the reconnection, although the ultrasound after tightening down the vessel showed something in the vessel. The surgeon did pulse probe on the vessel and did not get a pulse on 2 cm to 3 cm of the vessel. Further the x-ray was done which also confirmed that something was blocking the vessel. It was reported that the surgeon pulled out something which was blocking the vessel. According to sales representative, the surgeon pulled out legoo from the vessel. The ultrasound and angiogram was performed which confirmed that the vessel was completely open. The sales representative reported that the surgeon might have used the incorrect technique to dissolve the legoo plug. The surgeon pushed the legoo plug down the vessel and cold saline never got all the way through the legoo plug to dissolve it all. It was reported that trainer was also present during the surgery. On the same day, the patient recovered from the event of "continued to block the vessel". The outcome of the event of "legoo plug migrated down the vessel" was not provided. Concomitant medications were not provided. The intensity for both the events was not provided. The relationship between legoo and both the events was not provided by the reporting surgeon.
Patient Sequence No: 1, Text Type: D, B5
[18408514]
Manufacturer's comment: the benefit-risk relationship of legoo is not affected by this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008867907-2013-00005 |
| MDR Report Key | 3204219 |
| Report Source | 05,07 |
| Date Received | 2013-06-14 |
| Date of Report | 2013-06-10 |
| Date of Event | 2013-05-15 |
| Date Mfgr Received | 2013-06-10 |
| Date Added to Maude | 2013-07-16 |
| 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 MD 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| Manufacturer G1 | PLUROMED INC. |
| Manufacturer Street | 175 NEW BOSTON STREET |
| 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 | 2013-06-14 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNKNOWN |
| 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. Required No Informationntervention | 2013-06-14 |