BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24525372 · Received March 5, 2026

    Report

    Report Number
    1220648-2026-04579
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    December 21, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1: BRAND NAME UPDATED.

    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

    A 58-YEAR-OLD MALE WITH A HISTORY OF STEMI COMPLICATED BY BIVENTRICULAR CARDIOGENIC SHOCK UNDERWENT PLACEMENT OF AN IMPELLA CP PRIOR TO PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT CORONARY ARTERY. BECAUSE OF PERSISTENT RIGHT VENTRICULAR CARDIOGENIC SHOCK, A MULTIDISCIPLINARY HEART TEAM ELECTED TO IMPLANT AN IMPELLA RP FLEX, ESTABLISHING BIPELLA SUPPORT. ON DAY 2 OF BIPELLA SUPPORT, THE AUTOMATED IMPELLA CONSOLE (AIC) DISPLAYED THE FOLLOWING CHANGES FOR THE IMPELLA RP FLEX: RISE IN PULMONARY ARTERY (PA) PLACEMENT SIGNAL, DECLINE IN PUMP FLOW AND A SPIKE IN MOTOR CURRENT, RAISING CONCERN FOR BIOMATERIAL INGESTION. THE PATIENT'S SYSTEMIC ANTICOAGULATION WAS THERAPEUTIC AND THERE WERE NO ALARMS ON THE AIC. THE HEART TEAM WAS ADVISED TO USE ALTERNATIVE APPROVED DIAGNOSTIC DEVICES FOR HEMODYNAMIC MONITORING (E.G., PA CATHETER, ECHOCARDIOGRAPHY). LABORATORY EVALUATION REVEALED PLASMA FREE HEMOGLOBIN (PFHB) > 40 G/DL, CONSISTENT WITH HEMOLYSIS. DESPITE SIGNS OF HEMOLYSIS AND ABNORMAL PLACEMENT SIGNAL BEHAVIOR, THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND TOLERATED WEANING OF BOTH THE IMPELLA CP AND IMPELLA RP FLEX DEVICES." DURING BIPELLA SUPPORT WITH CP AND RP FLEX, THERE WAS A RISE IN PULMONARY ARTERY PLACEMENT SIGNAL (PAPS) WITH A DECREASE IN PUMP FLOWS AND SPIKE IN MOTOR CURRENT, FOLLOWING A PATIENT TURN. ANTICOAGULATION THERAPEUTIC WAS GIVEN. IT WAS NOTED THAT THERE WERE NO ACTIVE ALARMS. RN WAS INSTRUCTED TO REDUCE P LEVEL DOWN AND PAPI RETURNED AND IMPELLA FLOW IMPROVED, BUT IMPROVEMENTS WERE LOST WHEN RN RETURNED TO THE P LEVEL THE PUMP WAS PREVIOUSLY RUNNING AT. SAME ISSUE OCCURRED (DECREASE IN PUMP FLOW, MOTOR CURRENT SPIKE, AND INCREASE IN PAPS) A FEW DAYS LATER, FOLLOWING A COUGHING EPISODE. THIS IS CONSIDERED A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587293 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 2025528742 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention