BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25172589 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07827
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    February 20, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1, A4, AND A5 ARE UNKNOWN. 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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN D3( MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT THE INFORMATION WAS INADVERTENTLY NOT SUBMITTED IN THE INITIAL REPORT. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY, WITH SINGLE ACCESS USED FOR BOTH THE CP AND ANGIOPLASTY EQUIPMENT, TO SUPPORT A 72-YEAR-OLD MALE PATIENT. THE PATIENT HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP WAS PLACED AND THE PCI PERFORMED SUCCESSFULLY, HOWEVER THERE WERE 2 HARMS NOTED. THERE WAS AN ACCESS SITE BLEED THAT OCCURRED AFTER THE PATIENT SAT UP IN THE BED. THE TEAM APPLIED A MANUAL HOLD AND NEW DRESSING WAS PLACED. THERE WAS ECCHYMOSIS BUT, NO HEMATOMA WAS NOTED. THE TEAM MARKED THE BORDERS OF THE ECCHYMOSIS AND APPLIED A SANDBAG WHICH CONTRIBUTED TO THE RESOLUTION. NO FURTHER TREATMENT WAS DEEMED NECESSARY. ALSO, THE PATIENT HAD A RISE IN THE CREATININE LEVEL POST THE PCI. THE TEAM NOTED THE RENAL CONSULT DETERMINED THIS WAS CONTRAST INDUCED. THE CREATININE HAD RISEN FROM A BASELINE OF 1.43MG/DL TO A HIGH OF 2.28MG/DL. THERE WAS NO TREATMENT NOTED, NO DIALYSIS WAS INITIATED FOR THE RENAL INSUFFICIENCY/CHANGE IN RENAL FUNCTION. THE BLEED WAS MINOR AND THE CONTRAST INDUCED RENAL HARM BOTH CAN OCCUR WITH PCI AND CONTRAST MEDIA UTILIZED FOR IMAGING DURING A PCI. THE PATIENT HAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378592 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2025610715 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1