BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23826707 · Received December 17, 2025

    Report

    Report Number
    1220648-2025-49089
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 17, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. THE INVESTIGATION WAS COMPLETED AND NOTED A DEVICE HISTORY RECORD REVIEW CONFIRMED THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS. REGARDING THE ASAE/ MAJOR BLEED: MINIMAL OOZING AT CP SITE, HEPARIN OFF BUT UNKNOWN RESOLUTION, THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMART ASSIST SYSTEM SECTION: GENERAL PATIENT CARE CONSIDERATIONS ¿ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA.¿ SECTION: ENTERING CARDIAC OUTPUT USE OF THE REPOSITIONING SHEATH AND PEEL-AWAY INTRODUCER ¿REMOVE THE PEEL-AWAY INTRODUCER COMPLETELY FROM THE ARTERY OVER THE CATHETER SHAFT TO PREVENT TRAUMA AND SIGNIFICANT BLEEDING AND APPLY MANUAL PRESSURE ABOVE THE PUNCTURE SITE.¿ SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES) ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION).¿

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT IN WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT AS A BRIDGE TO AN IMPELLA 5.5 AND CORONARY ARTERY BYPASS GRAFT. THE PATIENT PRESENTED TO THE HOSPITAL WITH A TWO-WEEK HISTORY OF SHORTNESS OF BREATH AND AN ASSOCIATED EPISODE OF CHEST PAIN. DIAGNOSTIC TESTING UPON ADMISSION REVEALED ELEVATED TROPONIN AND BNP LEVELS AND A SUBSEQUENT CARDIAC CATHETERIZATION WAS PERFORMED AND RIGHT HEART CATHETERIZATION IDENTIFIED SEVERE DISTAL LEFT MAIN (LM) CORONARY ARTERY DISEASE. DUE TO THE SEVERITY OF THE FINDINGS AND THE PATIENT'S CLINICAL INSTABILITY, A "SHOCK CALL" WAS INITIATED AND THE DECISION WAS MADE TO PLACE IMPELLA CP SUPPORT AS A BRIDGE TO TRANSPORT TO ANOTHER HOSPITAL FOR A PLANNED ESCALATION TO IMPELLA 5.5 AND CORONARY ARTERY BYPASS GRAFT. THE IMPELLA CP WAS PREPPED, INSERTED VIA THE RIGHT FEMORAL ARTERY, AND SUPPORT WAS INITIATED WITH FLOWS AT 3.5 LITERS PER MINUTE WITHOUT COMPLICATIONS. THE PATIENT WAS STABILIZED AND PREPPED FOR TRANSFER TO ANOTHER HOSPITAL FOR ADVANCED TREATMENT. THE PATIENT WAS SUCCESSFULLY TRANSFERRED TO THE OUTSIDE HOSPITAL ON SUPPORT DAY TWO, AND THE PATIENT WAS NOTED TO BE IN STABLE CONDITION WITH SOME SHORTNESS OF BREATH. THERE WAS NOTED TO BE OOZING AT THE IMPELLA ACCESS SITE AND AS A RESULT OF THE OOZING, HEPARIN WAS DISCONTINUED. THE PATIENT CONTINUED TO DECOMPENSATE ON THE IMPELLA CP AND WAS TAKEN LATER THAT MORNING TO THE OPERATING ROOM FOR IMPELLA CP REMOVAL AND AN ESCALATION TO IMPELLA 5.5. THE IMPELLA 5.5 WAS PREPPED, INSERTED VIA THE RIGHT AXILLARY ARTERY, AND SUPPORT WAS INITIATED AS THE IMPELLA CP WAS PULLED ACROSS THE AORTIC VALVE, SUPPORT DISCONTINUED AND REMOVED. DURING THE IMPLANT OF THE IMPELLA 5.5, IT WAS REPORTED THERE WAS A CONTROLLER ERROR ON THE AUTOMATED IMPELLA CONTROLLER (AIC). SUPPORT FROM THE NEW IMPELLA 5.5 WAS NOT COMPROMISED DUE TO THE ERROR, HOWEVER THE DECISION WAS MADE TO REPLACE THE CONSOLE. AFTER THE BACK UP UNIT WAS OBTAINED, IT WAS NOTED THAT THE PUMP FLOWS AND PURGE SYSTEMS WERE RUNNING, AND THE CONTROLLER ALARM RESOLVED, HOWEVER THERE WAS A LOSS OF PLACEMENT SIGNAL AND MOTOR CURRENT. THE AIC WAS REPLACED WITH THE BACK UP UNIT, AND THE ISSUES WERE RESOLVED. THE IMPELLA CP ACCESS SITE WAS SURGICALLY REPAIRED FOR CLOSURE. THE PATIENT WAS TRANSPORTED TO THE INTENSIVE CARE UNIT FOR REST AND RECOVERY. ON IMPELLA 5.5 SUPPORT DAY THREE, IT WAS NOTED THAT THE PATIENT WAS BELIEVED TO BE IN SEPTIC SHOCK AND CARDIOGENIC SHOCK. THE PATIENT HAD A FEVER OF 38 CELSIUS AND WAS PLACED ON A COOLING BLANKET. BLOOD CULTURES AND A SPUTUM SAMPLE WERE SENT FOR BACTERIAL GROWTH. THE PATIENT WAS NOTED TO BE CRITICALLY ILL. ON SUPPORT DAY FOUR, THE PATIENT REMAINED FEBRILE. THE PATIENT¿S CARE PLAN WAS TO STABILIZE THE PATIENT UNTIL A PERCUTANEOUS CORONARY INTERVENTION (PCI) COULD BE PERFORMED. ON SUPPORT DAY SIX, THE PATIENT¿S URINE WAS NOTED TO BE PINK TINGED. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION. ON SUPPORT DAY SEVEN, THE MEDICAL TEAM CONTINUED TO HAVE CONCERN FOR THE PATIENT HAVING SEPSIS. THE MEDICAL TEAM DID NOT BELIEVE THAT THE IMPELLA ACCESS SITE WAS INFECTED. A PLAN WAS MADE TO START THE PATIENT ON ANTIBIOTICS AND TO PULL MORE CULTURES TO IDENTIFY THE PATHOGEN. THERE WAS ADDITIONALLY A CONCERN FOR AN ACUTE KIDNEY INJURY AS THE PATIENT¿S CREATININE LEVELS WERE INCREASING. ON SUPPORT DAY EIGHT, IT WAS NOTED THAT THE PATIENT RECEIVED MULTIPLE FLUID BOLUSES FOR LOW CENTRAL VENOUS PRESSURE AND SUCTION ALARMS. ON SUPPORT DAY NINE, IT WAS NOTED THAT THE PATIENT HAD SOME EPISODES OF VENTRICULAR TACHYCARDIA WHEN THE PATIENT COUGHED OR MOVED OVERNIGHT. LATER THAT DAY, THE PATIENT HAD A SUCCESSFUL PCI. FOLLOWING THE PCI THE PATIENT REMAINED ON IMPELLA 5.5 SUPPORT FOR REST AND RECOVERY. ON SUPPORT DAY 10, THE PATIENT REMAINED FEBRILE WITH UNCLEAR SOURCE OF INFECTION. ON SUPPORT DAY 11, THE CONCERN FOR INFECTION CONTINUED. THE PATIENT RECEIVED A WHOLE BODY COMPUTED TOMOGRAPHY SCAN TO ATTEMPT TO FIND A SOURCE OF INFECTION. THE PATIENT REMAINED ON ANTIBIOTICS, AND OF NOTE THE IMPELLA SITE WAS WITHOUT INFECTION CONCERN. ON SUPPORT DAY 13, IT WAS NOTED THAT THE PATIENT WAS NOT RESPONDING TO NEUROLOGICAL STIMULI. IT WAS REPORTED THAT THE AIC HAD AN ALARM FOR ¿UNEXPECTED CONTROLLER SHUT DOWN¿ WHICH SELF-RESOLVED. A BACK UP AIC WAS PLACED ON STANDBY, AND THE AIC WAS MONITORED. ON SUPPORT DAY 17, THE PATIENT HAD BLOODY DRAINAGE FROM A NASOGASTRIC TUBE AND HAD SLIGHT HEMATURIA. THE MEDICAL TEAM WAS ADVISED TO VERIFY PLACEMENT OF THE IMPELLA 5.5 WITH ULTRASOUND. THE PATIENT CONTINUED TO NOT FOLLOW COMMANDS BUT WAS NOTED TO MOVE SPONTANEOUSLY. ON SUPPORT DAY 18, A BEDSIDE ULTRASOUND REVEALED THE IMPELLA HAD MIGRATED, REQUIRING THE PHYSICIAN TO REPOSITION THE DEVICE BY PULLING IT BACK TWO CENTIMETERS INTO THE CORRECT POSITION. THE PATIENT¿S HEMATURIA WAS NOTED TO BE CLEARING; WHILE THE CAUSE IS UNCONFIRMED, IT MAY BE RELATED TO FOLEY CATHETER TRAUMA, AS PLASMA FREE HEMOGLOBIN LEVELS WERE WITHIN NORMAL LIMITS. ADDITIONALLY, A LARGE CLOT WAS IDENTIFIED DURING AN UPPER ENDOSCOPY AND REMOVED. THE HEPARIN IN THE IMPELLA PURGE SOLUTION WAS DISCONTINUED, AND THE PATIENT WAS EXTUBATED TO A HIGH FLOW NASAL CANNULA. ON SUPPORT DAY 19, THE PATIENT EXPERIENCED FLASH PULMONARY EDEMA AND REQUIRED EMERGENCY INTUBATION. THE PLANNED WEAN OF THE IMPELLA 5.5 WAS STOPPED, AND THE PERFORMANCE LEVEL WAS INCREASED TO P5 FROM P2. THE DEVICE WAS EXPLANTED SUCCESSFULLY AFTER WEANING. THE EXPLANT WAS NOT CONSIDERED PREMATURE AND WAS UNRELATED TO THE REPORTED COMPLICATION. THE PATIENT'S OUTCOME AT THE TIME OF EXPLANT WAS SURVIVED. THIS COMPLAINT INVOLVES FOUR IMPELLA DEVICES: PUMP 1: IMPELLA CP, WITH SERIAL NUMBER (B)(6). PUMP 2: IMPELLA 5.5, WITH SERIAL NUMBER (B)(6). AUTOMATED IMPELLA CONTROLLER 1 WITH SERIAL NUMBER (B)(6). AUTOMATED IMPELLA CONTROLLER 2 WITH SERIAL NUMBER (B)(6). THIS REPORT SPECIFICALLY ADDRESSES PUMP 1: IMPELLA CP, WITH SERIAL NUMBER (B)(6). SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER DEVICES ASSOCIATED WITH THIS COMPLAINT. REFER TO SECTION H10 FOR THE RELATED REPORT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274493 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026767844 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention