BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24433405 · Received February 24, 2026

    Report

    Report Number
    1220648-2026-03942
    Event Type
    Death
    Date Received
    February 24, 2026
    Date of Event
    February 16, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS BEING SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE CONFIRMING THAT THERE IS NO DEVICE AVAILABLE FOR RETURN. THIS INFORMATION IS CONSISTENT WITH THE INITIAL MDR, WHICH REPORTED THAT THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. AS NO DEVICE IS AVAILABLE, DEVICE EVALUATION COULD NOT BE PERFORMED. NO ADDITIONAL INFORMATION IMPACTING THE PREVIOUSLY REPORTED DEVICE RETURN STATUS IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    PAROXYSMAL ATRIAL FIBRILLATION/HYPOTENSION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. LOW OR BLOCKED PUMP FLOW: THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS NO PRODUCT OR LOGS WERE RETURNED FOR ANALYSIS ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D1 (BRAND NAME). ADDITIONAL INFORMATION (CODES) HAS BEEN PROVIDED IN H6 (COMPONENT CODE, INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, AND INVESTIGATION CONCLUSIONS).

    Additional Manufacturer Narrative · 0

    A4, A6 ARE UNKNOWN. 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. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA RP FLEX DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE AUTOMATED IMPELLA CONTROLLER.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: A 47-YEAR-OLD MALE PATIENT WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK (AMI/CGS) PRESENTED IN SCAI STAGE E SHOCK AND REQUIRED ESCALATING MECHANICAL CIRCULATORY SUPPORT. AN IMPELLA CP WAS FIRST IMPLANTED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY FOR LEFT SIDED SUPPORT. THE PATIENT SUBSEQUENTLY RECEIVED AN IMPELLA RP FLEX VIA THE LEFT FEMORAL VEIN THE SAME MORNING FOR RIGHT SIDED SUPPORT. DURING RP SUPPORT, THE AUTOMATED IMPELLA CONTROLLER (AIC) CONSOLE DISPLAYED ABSENT PULMONARY ARTERY PULSATILITY INDEX (PAPI) READINGS, ABNORMAL CENTRAL VENOUS PRESSURE (CVP) VALUES (-35), AND PLACEMENT SIGNAL CONCERNS, WITH IMAGING LATER CONFIRMING THE RP FLEX CATHETER TIP IN THE LEFT PULMONARY ARTERY (PA); ALL RELATED PRODUCTS WERE REQUESTED FOR RETURN, AND DATA DOWNLOADS WERE REQUIRED. SUCTION ALARMS WERE ALSO TRIGGERED ON BOTH CP AND RP; THE PATIENT WAS IN ATRIAL FIBRILLATION AND HAD LOW BLOOD PRESSURE. THE PATIENT ALSO WAS ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND THE AMOUNT OF FLUID TO BE PULLED OUT WAS INCREASED. DURING THESE EVENTS, BOTH DEVICES REMAINED IN PLACE AND SUPPORT CONTINUED. THE PATIENT ULTIMATELY EXPIRED, WITH CARE WITHDRAWN DURING IMPELLA SUPPORT. BASED ON THE AVAILABLE INFORMATION, THE REPORTED HEMODYNAMIC INSTABILITY, SUCTION EVENTS, ARRHYTHMIAS, AND ABNORMAL MONITORING PARAMETERS APPEAR CLINICALLY ATTRIBUTABLE TO THE PATIENT¿S PROFOUND CARDIOGENIC SHOCK AND MULTIORGAN PHYSIOLOGIC INSTABILITY, RATHER THAN TO INTRINSIC MALFUNCTION OF THE IMPELLA RP FLEX DEVICE. THE RP PLACEMENT SIGNAL ISSUE CORRESPONDED WITH CATHETER POSITION IN THE LEFT PULMONARY ARTERY, REFLECTING PATIENT SPECIFIC ANATOMY AND CLINICAL MANAGEMENT FACTORS, NOT A DEVICE DEFECT. THE DEATH IS CONSERVATIVELY BEING REPORTED ON THE IMPELLA RP FLEX BUT IS UNLIKELY A CONTRIBUTING FACTOR TO THE CAUSE OF DEATH AND IS MORE LIKELY DUE TO THE PATIENT¿S DECLINING CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309778 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2026814923 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1