IMPELLA RP

Additional Manufacturer Narrative

THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: IMPELLA RP WITH SMART ASSIST SYSTEM WITH AUTOMATED IMPELLA CONTROLLER SECTION: WARNINGS AND CAUTIONS ¿MAKE SURE THERE IS NO BLEEDING AT THE TRANSITION FROM THE REPOSITIONING SHEATH TO THE INTERNAL JUGULAR VEIN. CLOSE AND DRESS THE WOUND ¿BE SURE THAT THE STOPCOCK ON THE REPOSITIONING SHEATH IS ALWAYS KEPT IN THE CLOSED POSITION. SIGNIFICANT BLEED BACK CAN RESULT IF THE STOPCOCK IS OPEN.¿ ¿MAKE SURE THERE IS NO BLEEDING AT THE TRANSITION FROM THE REPOSITIONING SHEATH TO THE FEMORAL VEIN. CLOSE AND DRESS THE WOUND.¿ THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

Description of Event or Problem

THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK / LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING AFTER THE PEEL-AWAY SHEATH WAS REMOVED AND REPOSITIONING SHEATH WAS ADVANCED FORWARD. THE PHYSICIAN HELD PRESSURE AND PLACED A TIGHT MATTRESS SUTURE AROUND DEVICE. IT WAS REPORTED THAT THE BLEEDING WAS ABLE TO BE CONTROLLED AFTER INTERVENTIONS.