MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-05-20 for LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION UNK manufactured by Pluromed Inc.
[20236178]
Clot in graft proximal to anastomosis [graft thrombosis]. Case description: spontaneous report was received on (b)(6) 2013 from a physician via a sales rep regarding a (b)(6) male pt, initials (b)(6). The pt's medical history was not provided. On (b)(6) 2013, legoo (endovascular occlusion gel) was injected in an unspecified vessel during a femoral tibial bypass surgery, for vascular occlusion. It was reported that the pt had a clot formed in graft proximal to anastomosis. The clot formed about 30 minutes after using legoo. The company assessed the event of clot in graft proximal to anastomosis as medically significant. It was further reported that the surgeon was able to fix the clot and the surgery proceeded without any further issues. The same day, the pt recovered from the event. Concomitant medications were not provided. The intensity for the event of clot in graft proximal to anastomosis was not provided. The reporting physician did not provide the relationship between legoo and the event of clot in graft proximal to anastomosis.
Patient Sequence No: 1, Text Type: D, B5
[20491807]
Mfr's comment: the benefit-risk relationship of legoo is not affected by this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008867907-2013-00003 |
| MDR Report Key | 3173445 |
| Report Source | 05,07 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-05-17 |
| Date of Event | 2013-05-14 |
| Date Mfgr Received | 2013-05-14 |
| Date Added to Maude | 2013-06-18 |
| 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 ST |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| Manufacturer G1 | PLUROMED INC |
| Manufacturer Street | 175 NEW BOSTON ST |
| 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 | 2013-05-20 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 021413-05 |
| 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. Other | 2013-05-20 |