BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24569226 · Received March 11, 2026

    Report

    Report Number
    1220648-2026-05038
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D1 (BRAND NAME). UPON REVIEW, IT WAS IDENTIFIED THAT THE SECTION D BRAND NAME HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN D3, G1 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN E3 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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

    ADDITIONAL INFORMATION HAS BEEN RECEIVED UPON REQUEST: "PT HAS RECOVERED AND NO ISSUES WITH IMPELLA DEVICE. ISSUE HAD NOTHING TO DO WITH PUMP. RETURN KIT NOT NEEDED."

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 50-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) AND RENAL INSUFFICIENCY, PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), ON A VENOUS-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO), IN SCAI STAGE E SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. A WEEK AFTER IMPELLA INSERTION, THE DEVICE WAS REMOVED WITH AN ESCALATION OF THERAPY TO AN IMPELLA 5.5. WHILE UPGRADING TO THE 5.5, THE VA ECMO ARTERIAL CANNULA WAS PULLED OUT OF THE ARTERY, WHICH CAUSED THE PATIENT TO DECOMPENSATE INTO CARDIAC ARREST. A NEW ARTERIAL CANNULA WAS PLACED AT THE IMPELLA CP SITE. ONCE RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS OBTAINED, THE PATIENT WAS PLACED BACK ON ECMO, AND THE IMPELLA 5.5 WAS INSERTED. DUE TO THE LONG CODE, THE RIGHT VENTRICLE (RV) WAS DOWN WITH NO MOVEMENT TO THE LEFT SIDE. THE IMPELLA 5.5 WAS ONLY ABLE TO FUNCTION AT 0.5-2.0L/MIN DEPENDING ON ECMO FLOWS. A REPAIR OF THE ARTERY OF THE ARTERIAL CANNULA WAS REQUIRED. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA CP FUNCTIONED AT P-6 AT 2.8L/MIN AS INTENDED. THE VASCULAR DISSECTION THAT CAUSED THE PATIENT TO DECOMPENSATE CAN BE ATTRIBUTED TO USER ERROR. THE IMPELLA IS CONSERVATIVELY BEING REPORTED FOR SERIOUS INJURY; HOWEVER, DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630690 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026731899 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention