BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24497090 · Received March 3, 2026

    Report

    Report Number
    1220648-2026-04404
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    November 2, 2025
    Report Date
    April 29, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    61-YEAR-OLD MALE PATIENT TREATED WITH IMPELLA CP DUE TO ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. PATIENT HAD PREVIOUS OUTSIDE OF FACILITY CARDIAC ARREST. PATIENT HAD BASIC LIFE SUPPORT FOR 20 MINUTES PROVIDED OUTSIDE HOSPITAL, WAS RESUSCITATED SUCCESSFULLY AND WAS TRANSPORTED VIA EMERGENCY TRANSPORT TO HOSPITAL. LABS AND ECG INDICATED ST ELEVATION MYOCARDIAL INFARCTION. PATIENT THEN PROMPTLY BROUGHT TO CATHETERIZATION LABORATORY FOR IMPELLA CP PLACEMENT AND PERCUTANEOUS CORONARY INTERVENTION. DAY ONE OF PLACEMENT PATIENT WAS PLANNED TO REST TO RECOVER SHOCK STATE, ECHO BEDSIDE INDICATED, THAT THE PIGTAIL IS UNDERNEATH THE PAPILLARY MUSCLE OF THE MITRAL VALVE. THE INLET IS FREE FROM OBSTRUCTION AND FLOWING WITHOUT ALARMS - HCP CONFIRMED, THAT PLACEMENT IS OK FOR NOW. DAY ONE OF SUPPORT, IT WAS NOTED, THAT PATIENT ARTERIAL BLOOD PRESSURE READING ROUGHLY 20MMHG, WHICH IS DIFFERENT FROM AORTIC PLACEMENT SIGNAL. HCP CONFIDENT THAT OPTICAL SENSOR IS FAULTY AND THAT PATIENT ARTERIAL BLOOD PRESSURE IS CORRECT. SECOND DAY OF SUPPORT OOZING WAS NOTED WITHOUT FURTHER EXPLANATION - THEREFORE CODED TO MINOR BLEED AND MINOR INJURY AS WELL AS REPOSITIONING AS THIS WAS DONE BEDSIDE THIS DAY. PATIENT BEING TREATED WITH FLUID BOLUS AND BLOOD PRODUCTS TO IMPROVE IMPELLA FLOW - CODED HERE CONSERVATIVELY TO ANEMIA AND MEDICATION REQUIRED. ANTEGRADE SHEATH NECESSARY TO PROVIDE DISTAL LIMB PERFUSION - THEREFORE CODED HERE FOR ISCHEMIA AND SERIOUS INJURY. PATIENT DESCRIBED AS VASOPLEGIC, THEREFORE CODED HERE AS CARDIOGENIC SHOCK. IMPELLA PUMP HAD BEEN HOOKED TO PAPILLARY MUSCLE SINCE INSERTION. PATIENT SUCCESSFULLY WEANED ON DAY FOUR OF SUPPORT. THE OCCURRENCE OF ANEMIA AND/OR THE REQUIREMENT FOR BLOOD TRANSFUSION DURING IMPELLA SUPPORT ARE MOST PLAUSIBLY MULTIFACTORIAL IN ORIGIN. IMPELLA CP: DEVICE IN WRONG POSITION (SOURCES: 11/2, 11/4, 11/5 PT. UPDATE NOTES) DURING IMPELLA CP SUPPORT, THE PATIENT EXPERIENCED ISSUES WITH THE DEVICE IN THE WRONG POSITION. THE PHYSICIAN WAS AWARE PIGTAIL HAD BEEN HOOKED ON THE PAPILLARY MUSCLES SINCE IMPLANT BUT WAS OKAY WITH PLACEMENT UNTIL A COUPLE DAYS LATER WHEN A CONSISTENT "PLACEMENT SIGNAL LOW" ALARM WAS PRESENT. THE CARE TEAM OPTED TO REPOSITION THE PUMP, NOTING THAT THE PUMP HAD MIGRATED CLOSER TO THE VALVE. THE PUMP WAS REPOSITIONED WITH ECHO AT BEDSIDE TO MEASURE 3.8CM FROM THE VALVE AT P5. IT IS UNCLEAR FROM THE DETAILS AVAILABLE WHETHER THE REPOSITIONING ALSO THE PIGTAIL WAS FREED FROM THE PAPILLARY MUSCLES. THE PLACEMENT SIGNAL LOW ALARM REMAINED AFTER REPOSITIONING AND WERE REPORTED TO HAVE SELF-RESOLVED WITH A DAY. PLACEMENT SIGNAL ISSUE ON DAY 2 OF IMPELLA CP SUPPORT, THERE WAS A PLACEMENT SIGNAL ISSUE. THE PATIENT'S ARTERIAL BLOOD PRESSURE WAS MEASURED TO BE ROUGHLY 20 MMHG DIFFERENT THAN THE IMPELLA CP'S AORTIC PLACEMENT SIGNAL MEASUREMENT. THE ABIOMED REPRESENTATIVE STATED THAT DESPITE THE PATIENT'S ACUTE ILLNESS AND HYPOTENSION, THE PHYSICIAN WAS CONFIDENT THE IMPELLA CP'S OPTICAL SENSOR READING WAS INACCURATE THE ARTERIAL BLOOD PRESSURE MEASUREMENT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155234 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2022038660 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1