LEGOO CS-50 ENDOVASCULAR OCCLUSION GEL M607CS-50

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-09-11 for LEGOO CS-50 ENDOVASCULAR OCCLUSION GEL M607CS-50 manufactured by Pluromed Inc..

Event Text Entries

[2879299] Intraoperative episode of myocardial ischemia, hemodynamic compromise and poor pulse in the lad. Initial report received from cardiac surgeon via a sales representative on (b)(6) 2012 and subsequently via phone call on (b)(6) 2012, regarding a (b)(6) male pt with a pmh of multiple left anterior descending artery (lad) and right coronary artery (rca) stentings, and a recent angiogram showing 40% stenosis of left main artery, and suggested anterior wall revascularization while his rca stenting area looked fine. In addition the pt had an ejection fraction of approximately 40%, a 50-69% left carotid stenosis, and mild aortic disease. Vessels diameters were reported as: maximal ascending aortic diameter of 3. 65 cm. The lad diameter was 2 mm, the obtuse marginal artery (om) diameter was 2. 25 mm. The pt was experiencing recurrent angina and had a positive stress test on an unk date. He underwent an off-pump cabg on (b)(6) 2012. The surgeon planned to do an end-to-side anastomosis on the target vessels. Legoo cs-50 (0. 5ml syringe) was injected into the lad. The surgeon estimated that of the provided volume, approx 3/4 of legoo was injected proximally and 1/4 distally to help hemostasis. The left internal mammary artery (lima) was snared proximally to the lad. Cold saline irrigation was used to dissolve the legoo. Legoo plugs washed and flow was good, the final suture was tied down. During positioning of the heart to expose the om, a hemodynamic compromise was noted ("the pt was struggling"), and the surgeon noticed a poor pulse in the lad, considered as an episode of intraoperative myocardial ischemia. This prompted the surgeon to perform another vein graft to the lad distal to the lima graft (bridge graft). After placing this graft, the pt improved. No ekg changes were noted during the ischemic period or postoperatively, and the cardiac enzymes were negative postoperatively. The surgeon continued the procedure and the om was then grafted. In total the following grafts were performed: lima to lad; saphenous vein graft to lad, saphenous vein graft to om. The pt had an uneventful post-operative course. The surgeons' assessment of the relation of intraoperative episode of myocardial ischemia and legoo was possibly related. Summary of complaint investigation report: lot history records were reviewed and there were no deviations or non-conformances that would effect the quality of lot 062312-02. The lot met release specifications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008867907-2012-00002
MDR Report Key2748711
Report Source07
Date Received2012-09-11
Date of Report2012-09-11
Date of Event2012-08-14
Date Mfgr Received2012-08-15
Device Manufacturer Date2012-06-23
Date Added to Maude2012-09-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJOSEPH PELLETIER
Manufacturer Street175 NEW BOSTON STREET
Manufacturer CityWOBURN MA 01801
Manufacturer CountryUS
Manufacturer Postal01801
Manufacturer Phone7819320574
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEGOO CS-50 ENDOVASCULAR OCCLUSION GEL
Generic NameENDOVASCULAR OCCLUSION GEL
Product CodeOBC
Date Received2012-09-11
Model NumberCS-50
Catalog NumberM607CS-50
Lot Number062312-02
Device Expiration Date2014-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPLUROMED INC.
Manufacturer Address175 NEW BOSTON STREET WOBURN MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-09-11

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