MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,03,05 report with the FDA on 2014-12-03 for LEGOO (LEGOO) manufactured by Pluromed, Inc.
[5206884]
This summary solicited device case from (b)(6) was received on (b)(6) 2014 via conference abstract: wimmer gg, bouchot o, verhoye j, perrault lp, boergermann j, diegeler a et al. Randomised clinical trial comparing a thermosensitive polymer (legoo) versus conventional vessel loops for temporary coronary artery occlusion during off-pump coronary artery bypass surgery. At the 24th annual meeting of the european association for cardio-thoracic surgery, eacts 2010; 09/11/2010 - 09/15/2010; geneva, switzerland. Interact. Cardiovasc. Thorac. Surg. 2010; 11 suppl 2: s116-17. From this publication, one additional case reported was: (b)(6) (cluster case). This case concerns three patients (demographics not provided) who experienced myocardial infarction after receiving treatment with legoo. The patients medical history, concomitant medication and past drugs were not reported. On unk dates, the patients' undergoing off pump coronary artery bypass surgery were randomized to use legoo (form, route, dose, frequency, batch/lot number and expiration date: not reported) into unspecified vessel for temporary vascular occlusion. On unk dates, after unk latency, the patients experienced myocardial infarction (adverse event to legoo). Action taken: unk, corrective treatment: not reported, outcome: unk, seriousness criteria: important medical event, reporter causality: associated (adverse event to legoo), company causality: associated, a pharmaceutical tech complaint (ptc) was initiated and ptc results were pending for the same.
Patient Sequence No: 1, Text Type: D, B5
[12711623]
Important medical event. Sanofi company comment dated 12/01/2014: this is an initial literature case concerning three patients in whom legoo used for temporary vascular occlusion and developed myocardial infarction. Evaluating the indication for use, the role of legoo cannot be completely ruled out for the causation of event. However, no info regarding concomitant medications, the underlying concurrent medical conditions and the post-operative condition of the patient makes the complete medical assessment of the case difficult.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008867907-2014-64089 |
| MDR Report Key | 4307941 |
| Report Source | 01,02,03,05 |
| Date Received | 2014-12-03 |
| Date of Report | 2014-11-23 |
| Date Mfgr Received | 2014-11-23 |
| Date Added to Maude | 2014-12-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KRISTEN SHARMA, MD |
| Manufacturer Street | 55 CORPORATE DR MAIL STOP: 55C-235A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089812784 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGOO (LEGOO) |
| Generic Name | OBC |
| Product Code | OBC |
| Date Received | 2014-12-03 |
| Lot Number | UNK |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2014-12-03 |