CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION

Description of Event or Problem

LEFT VENTRICULAR DYSFUNCTION [LEFT VENTRICULAR DYSFUNCTION]. HEART DID NOT WORK [COMPLICATIONS OF TRANSPLANTED HEART]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A MALE PT (AGE 50-60), INITIALS UNK. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE HEART FOR TRANSPLANT WAS PRESERVED WITH CELSIOR. LATER, THE PT UNDERWENT HEART TRANSPLANT. THE LOT NUMBER FOR CELSIOR WAS NOT PROVIDED. IT WAS REPORTED THAT THE PT HAD GENERALISED DYSFUNCTION OF HEART AND PROFOUND LEFT VENTRICULAR DYSFUNCTION. THE COMPANY ASSESSED THE EVENT OF LEFT VENTRICULAR DYSFUNCTION AS MEDICALLY SIGNIFICANT. AT THE TIME OF REPORT, THE PT HAD NOT YET RECOVERED FROM BOTH THE EVENTS. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR BOTH THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE THE CAUSAL RELATIONSHIP OF CELSIOR WITH BOTH THE EVENTS.

Additional Manufacturer Narrative

AS ONLY LIMITED INFO HAS BEEN OBTAINED SO FAR, IT IS DIFFICULT TO ASSESS A CAUSE AND EFFECT RELATIONSHIP.