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..
[18924651]
This solicited device case from (b)(6) was received on (b)(6) 2014 via conference abstract: wimmergg, bouchot o, verhoye j, perrault lp, boergermann j, diegeler a et al. Randomised clinical trail comparing a thermosensitive polymer (legoo) versus conventional vessel loops for temporary coronary artery occlusion during off-pump coronary artery bypass surgery. Twenty-fourth annual meeting of the european association for cardio-thoracic surgery, eacts 2010; 2010 sep 11-15; geneva, switzerland. Interact. Cardiovasc. Thorac. Surg. 2010. 2010; 11 suppl 2:s116-17. From this publication, one additional case reported was: (b)(6)(cluster case). This case concerns a patient (demographics not provided) who died (unknown cause) after receiving treatment with legoo. The patient's medical history, concomitant medication and past drugs were not reported. On an unknown date, the patient was undergoing off pump coronary artery bypass surgery and was randomized to use legoo (form, route, dose, frequency, batch/lot number and expiration date: not reported) into unspecified vessel for temporary vascular occlusion. On an unknown date, after unknown latency, the patient died due to unknown cause. It was unknown if autopsy was done. Reporter causality: related (adverse event to legoo). Company causality: associated. A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending for the same.
Patient Sequence No: 1, Text Type: D, B5
[19045606]
Pharmacovigilance comment: sanofi company comment dated 28-nov-2014: this is an initial literature case concerning a patient in whom legoo was used for temporary vascular occlusion and died after coronary artery bypass surgery. Evaluating the indication for use the role of legoo cannot be completely ruled out for the causation of event. However no information regarding the underlying cocurrent medical conditions, the post-operative condition of the patient and complete lack of information regarding cause of death and autopsy details makes the complete medical assessment of the case difficult.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008867907-2014-65099 |
| MDR Report Key | 4307587 |
| 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 | 2014-12-10 |
| 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 DRIVE 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) |
| 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. Death | 2014-12-03 |