CELSIOR
Received Jun 8, 2007 · Event occurred Jan 1, 2007
Report 2950168-2007-00003 · MDR key 863316
Device
Product problems
- Malfunction
Patient
YR
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
HEART GRAFT VENTRICULAR DYSFUNCTION. SPONTANEOUS REPORT RECEIVED ON 23 MAY 2007 FROM A PHYSICIAN ASSISTANT REGARDING A HEART TRANSPLANT PATIENT (IDENTIFIERS NOT PROVIDED). THE PATIENT RECEIVED A HEART GRAFT THAT HAD BEEN PRESERVED WITH CELSIOR (DATE OF TRANSPLANT AND ELAPSED TIME OF PRESERVATION WERE NOT PROVIDED) IN 2007. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. DURING OR IMMEDIATELY POST, THE HEART TRANSPLANT (ELAPSED TIME NOT PROVIDED), THE PATIENT EXPERIENCED HEART GRAFT VENTRICULAR DYSFUNCTION. IT WAS THE OPINION OF THE PHYSICIAN ASSISTANT THAT THE EVENT WAS POSSIBLY RELATED TO CELSIOR. NO FURTHER INFORMATION WAS PROVIDED. MANUFACTURER'S COMMENT: THIS IS CASE REPORT 3 OF 6 FROM THIS REPORTER; PLEASE REFER TO CELS-10025, 10027, 10028, 10029, AND 10030 FOR ADDITIONAL CASE REPORTS OF HEART GRAFT VENTRICULAR DYSFUNCTION.
Additional Manufacturer Narrative
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