BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23936255 · Received December 31, 2025

    Report

    Report Number
    1220648-2025-49695
    Event Type
    Death
    Date Received
    December 31, 2025
    Date of Event
    September 14, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY/CLINICAL REVIEWED THE EVENT. THE PATIENT WAS ADMITTED FOR PRESUMED ST ELEVATION MYOCARDIAL INFARCTION; LEFT/RIGHT HEART CATHETERIZATION DEMONSTRATED CLEAN CORONARIES. THE PATIENT EXPERIENCED CARDIAC ARREST AND WAS PLACED ON BIVENTRICULAR MECHANICAL CIRCULATORY SUPPORT, WITH LEFT-SIDED IMPELLA SUPPORT IMPLANTED VIA THE RIGHT FEMORAL ARTERY DURING CARDIOPULMONARY RESUSCITATION, FOLLOWED BY IMPELLA RP FLEX IMPLANTATION VIA THE RIGHT FEMORAL VEIN. RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED; HOWEVER, THERE WAS NO VENTRICULAR PULSATILITY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT ON BIVENTRICULAR SUPPORT WITH MAXIMAL VASOPRESSOR AND INOTROPIC THERAPY. THE PATIENT REMAINED IN REFRACTORY SHOCK WITH ANURIA, NO NEUROLOGICAL RESPONSE, RENAL FAILURE, AND PROGRESSIVE MULTISYSTEM ORGAN FAILURE ALL KNOWN FACTORS OF PATIENTS IN CARDIOGENIC SHOCK. AFTER DISCUSSION WITH THE FAMILY, FURTHER ESCALATION OF CARE WAS DEFERRED, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. CONSERVATIVELY, THE DEATH WILL BE REPORTED ON BOTH IMPELLA DEVICES AS THE IMPELLA DEVICES WERE IN USE AT TIME OF EXPIRATION. DATE OF DEATH: THE EXACT DATE OF DEATH IS UNKNOWN BUT HAS BEEN CAPTURED AS THE DATE OF EXPLANT. IF ACTUAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CHANGE IN REPORTABILITY: AFTER REVIEW OF THE CASE BY MEDICAL SAFETY, IT WAS DETERMINED THE IMPELLA CP IS A DEATH TYPE OF REPORTABLE EVENT. SECTIONS B1 (ADVERSE EVENT/PRODUCT PROBLEM), B2 (OUTCOMES ATTRIBUTED), H1 (TYPE OF REPORTABLE EVENT) AND H6 (HEALTH EFFECT-CLINICAL AND IMPACT CODES) HAVE BEEN UPDATED, CORRECTED ACCORDINGLY. NOTE: H6: DEVICE PROBLEM/COMPONENT/INVESTIGATION CODING REMAINS UNCHANGED. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Additional Manufacturer Narrative · 0

    THE IMPELLA PASSED ALL THE POST STERILE INSPECTION CHECKS. THE ROOT CAUSE OF THE CARDIAC FAILURE WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE RENAL FAILURE AND ORGAN FAILURE WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP WENT INTO RENAL FAILURE AND END ORGAN FAILURE WITH DIFFUSE SHOCK. THE PUMP WAS EXPLANTED AND EXCHANGED FOR AN IMPELLA RP FLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2708430 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026655108 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention