STARFISH 2 HEART POSITIONER

Additional Manufacturer Narrative

(B)(4): EVALUATION METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: OTHER: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: FURTHER INVESTIGATION WAS PERFORMED IN RESPONSE TO THE USER FACILITY MEDWATCH RECEIVED. ADDITIONAL INFO WAS RECEIVED THAT WHILE REPOSITIONING THE STARFISH SOME EPICARDIAL TISSUE SLIGHTLY TORE AND CAUSED MINOR BLEEDING. THE TEAR WAS REPAIRED SUCCESSFULLY. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE WITHOUT FURTHER COMPLICATIONS. IT WAS REPORTED THAT THE PT WAS VERY SICK AND LATER DIED; HOWEVER, THE PHYSICIAN STATED THAT THE PT'S DEATH HAD NOTHING TO DO WITH THE STARFISH OR THE MINOR INCIDENT RELATED TO THE DEVICE. THE DEVICE WAS NOT SAVED BY THE PHYSICIAN AND THE LOT NUMBER COULD NOT BE RETRIEVED. THIS PRODUCT IS DESIGNED TO HOLD THE HEART IN PLACE. SHIFTING OF THE POSITIONER AND SLIDING IT ALONG THE HEART WITH TOO MUCH PRESSURE, COULD POTENTIALLY CAUSE TISSUE DAMAGE, PARTICULARLY IF THE PT'S HEART AND/OR TISSUES ARE NOT IN GOOD SHAPE. BASED ON THE AVAILABLE INFO, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED NOR DENIED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER COULD NOT BE RETRIEVED. CONCLUSION: WITH NO PRODUCT RETURN AND NO LOT INFO PROVIDED, NO FURTHER INVESTIGATION CAN BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. MEDTRONIC WILL CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR ISSUES.