MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,03,05 report with the FDA on 2013-01-15 for LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTION UNK manufactured by Pluromed Inc..
[3368691]
Doppler signal not satisfactory (poor blood flow) [directional doppler flow tests abnormal]. Undissolved polymer plug [device issue]. Case description: literature-spontaneous report was received on 12/12/2012 from an author regarding a patient (demographics not provided), initials unknown. This report was from a literature article entitled "a novel reverse thermosensitive polymer to archive temporary atraumatic vessel occlusion in infra-popliteal bypasses". The patient's medical history was significant for severe leg ischemia. On an unspecified date, the patient received legoo injection, intravascularly locally, one syringe of 1 ml for distal vessel control during infra-popliteal bypass surgery in severe leg ischemia. The lot number for legoo was not provided. On an unspecified date, doppler signals on the target vessel distal to the anastomoses were not satisfactory (poor blood flow). The patient's intra-operative angiography was performed. This showed evidence of run-off occlusion potentially due to the remaining intra-arterial polymer plug. Fogartys catheter was used to retrieve the undissolved polymer drug and the patient's back flow was successfully re-established. The action taken with legoo was not provided. Relevant concomitant medications were not provided. The reporter assessed the casual relationship between legoo and both the events as possible.
Patient Sequence No: 1, Text Type: D, B5
[10354100]
Additional information was received on 12/17/2012 in the form of a qa investigation. Evaluation summery: as no lot number was provided, a lot investigation could not be performed. Manufacturer's comment: the benefit-risk relationship of legoo is not affected by this report. Journal: european journal of vascular and endovascular surgery. Author: mani k, campbell a, fitzpatrick j et al. Title: a novel reverse thermosensitive polymer to achieve temporary atraumatic vessel occlusion in infra-popliteal bypasses. Year: 2012, pages: 1-5.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008867907-2012-00003 |
| MDR Report Key | 2922226 |
| Report Source | 00,01,03,05 |
| Date Received | 2013-01-15 |
| Date of Report | 2012-12-12 |
| Date Mfgr Received | 2012-12-12 |
| Date Added to Maude | 2013-02-13 |
| 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 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 | 2013-01-15 |
| 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. Required No Informationntervention | 2013-01-15 |