BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24498231 · Received March 3, 2026

    Report

    Report Number
    1220648-2026-04410
    Event Type
    Death
    Date Received
    March 3, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 15, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    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

    UPDATED INFORMATION: D1 BRAND NAME UPDATED. G1 MFR CONTACT FAX NUMBER ADDED. H6 MED DEV PROB CODE ADDED A050401.

    Description of Event or Problem · 0

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA RIGHT FEMORAL ARTERY IN A 86 YEAR OLD MALE FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE E. PRIOR TO CP PLACEMENT, THE PATIENT HAD TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), CODED AND REQUIRED CARDIOPULMONARY RESUSCITATION. AFTER CP PLACEMENT, WHILE STILL IN THE CATHETERIZATION LAB, BLOOD WAS OOZING FROM THE IMPELLA SITE. THE TAVR 14FR SHEATH HAD BEEN REMOVED AND REPLACED WITH A 14FR PEEL AWAY SHEATH. IT WAS REPORTED THE BLUE SUTURE HUB WAS DEEP IN THE PATIENT'S SKIN, AND BLEEDING WAS OCCURRING BETWEEN THE BLUE HUB AND THE CONNECTION TO THE LOCKING STERILE COVER. THE SHEATH WAS PULLED BACK AND HEMOSTASIS ACHIEVED AFTER 20 MINUTES OF MANUAL PRESSURE APPLIED. THE ACTIVATED CLOTTING TIME (ACT) AT THE TIME OF BLEED WAS 308. ON DAY 2 OF SUPPORT, WHILE IN THE INTENSIVE CARE UNIT, CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. BLEEDING AND DEATH ARE KNOWN RISKS ASSOCIATED WITH IMPELLA CP AS DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51856 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026754220 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1