BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24519036 · Received March 5, 2026

    Report

    Report Number
    1220648-2026-04523
    Event Type
    Death
    Date Received
    March 5, 2026
    Date of Event
    February 24, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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.

    Additional Manufacturer Narrative · 0

    DEVICE IN WRONG POSITION: THE CAUSE OF THE POSITIONING ISSUE WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. TACHYCARDIA: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D1 (BRAND NAME). ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H6 (COMPONENT CODE, INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, AND INVESTIGATION CONCLUSIONS).

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED PERCUTANEOUSLY INTO THE LEFT FEMORAL ARTERY IN A 30-YEAR-OLD FEMALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION (AMI) IN CARDIOGENIC SHOCK (CGS) SCAI STAGE E SHOCK REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), AFTER APPROXIMATELY ONE AND A HALF DAYS OF IMPELLA SUPPORT, THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA. TREATMENT INCLUDED LIDOCAINE AND AMIODARONE. AN ECHOCARDIOGRAM SHOWED THE IMPELLA PIGTAIL WAS POINTED TOWARD THE MITRAL VALVE APPARATUS. THERE WERE NO KINKS IN THE CANNULA OR CATHETER. THE PHYSICIAN PLANNED TO ATTEMPT TO REPOSITION THE IMPELLA AT THE BEDSIDE, AND IF NEEDED WOULD TRANSFER THE PATIENT TO THE CARDIAC CATHETERIZATION LAB (CCL) FOR REPOSITIONING UNDER FLUOROSCOPY. THE IMPELLA DEVICE WAS REPOSITIONED; HOWEVER, IT IS UNKNOWN IF REPOSITIONING THE DEVICE RESOLVED THE ISSUE. THE PATIENT SUBSEQUENTLY EXPIRED. CARE WAS WITHDRAWN AND THE POST-PROCEDURE OUTCOME WAS EXPIRED AT EXPLANT. ARRHYTHMIAS, INCLUDING VENTRICULAR TACHYCARDIA, CAN BE DRIVEN BY THE MECHANICAL INTERACTION OF THE IMPELLA DEVICE WITHIN THE HEART OR POSITION RELATED. ARRHYTHMIAS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS AND ARE COMMON IN PATIENTS EXPERIENCING AMI AND CGS. THE IMPELLA DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT¿S DEATH, WHICH WAS MOST LIKELY DUE TO THE PATIENT¿S UNDERLYING CLINICAL CONDITION, AS THE PATIENT PRESENTED WITH AMI IN CGS SCAI STAGE E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79452 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026812514 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention| D