BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24903390 · Received April 16, 2026

    Report

    Report Number
    1220648-2026-06877
    Event Type
    Death
    Date Received
    April 16, 2026
    Date of Event
    April 12, 2026
    Report Date
    April 22, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    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 B1 (IS ADVERSE EVENT), D3 (MANUFACTURER FAX), E4 (REPORTER ALSO SENT REPORT TO FDA?), H4 (DEVICE MANUFACTURE DATE). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (SERIAL, PRIMARY UDI NUMBER). UPON REVIEW, THE SECTION D PRIMARY UDI AND SERIAL NUMBER HAVE NOW BEEN UPDATED. 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. THE CAUSE OF THE DELIVERY ISSUE WAS LIKELY PATIENT CONDITION RELATED AS CLINICAL INFORMATION MENTIONED FAILED ATTEMPTS AND IMAGING REVEALING COMPLETELY OBSTRUCTED AXILLARY ARTERY.

    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 PROVIDED UPON REQUEST: "THOSE OTHER CATHETERS WERE NON ABIOMED DEVICES."

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS ATTEMPTED VIA A RIGHT SURGICAL ARTERIAL (AXILLARY) APPROACH IN A 64-YEAR-OLD FEMALE PATIENT FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE¿E CARDIOGENIC SHOCK. ONCE THE GRAFT WAS ATTACHED TO THE RIGHT AXILLARY ARTERY AND THE PEEL-AWAY SHEATH WAS INSERTED, THE IMPLANTING PHYSICIAN ATTEMPTED TO CROSS THE ANASTOMOSIS USING MULTIPLE DIFFERENT WIRES AND CATHETERS, WITHOUT SUCCESS. CONTRAST IMAGING WAS SUBSEQUENTLY PERFORMED AND REVEALED A COMPLETELY OBSTRUCTED AXILLARY ARTERY. BASED ON THESE FINDINGS, THE PROCEDURE WAS ABORTED, AND TIME OF DEATH (TOD) WAS CALLED. THE PATIENT EXPIRED. HOWEVER, BASED ON THE AVAILABLE CLINICAL INFORMATION, THE DEATH IS MORE LIKELY ATTRIBUTABLE TO THE PATIENT¿S UNDERLYING CRITICAL CONDITION, INCLUDING SEVERE AMI/CGS AND SCAI STAGE¿E CARDIOGENIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63667 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026815939 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1