MAUDE Adverse Event Report: PLUROMED INC. LEGOO (LEGOO)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: LEGOO (LEGOO)
• Manufacturer (Section D): PLUROMED INC.; woburn MA
• Manufacturer Contact: kristen sharma, md ; 55 corporate drive; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4307587
• MDR Text Key: 18924651
• Report Number: 3008867907-2014-65099
• Device Sequence Number: 1
• Product Code: OBC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CON MEDS = UNKNOWN; PREV MEDS = UNKNOWN
• Patient Outcome(s): Death