BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25045587 · Received April 30, 2026

    Report

    Report Number
    1220648-2026-07285
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 9, 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

    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

    D4 UDI REVISED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN B1 (IS PRODUCT PROBLEM). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM 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 CATHETER PRODUCT DAMAGE (KINK) WAS DETERMINED DUE TO BE PATIENT CONDITION RELATED SINCE THE PATIENT HAD TORTUOSITY AND PREVIOUS ILIAC STENTS WHICH WERE LIKELY THE CONTRIBUTING FACTORS. THE CAUSE OF THE FAILURE TO ADVANCE WAS DETERMINED TO BE PATIENT CONDITION RELATED SINCE THE PATIENT HAD TORTUOSITY AND PREVIOUS ILIAC STENTS WHICH WERE LIKELY THE CONTRIBUTING FACTORS TO THE SHEATH KINK THAT LED TO THE DELIVERY ISSUE.

    Additional Manufacturer Narrative · 0

    SECTION D4 CATALOG NUMBER WAS CORRECTED. SECTION D4 SERIAL NUMBER WAS CORRECTED. CORRECTION H6 MEDICAL DEVICE PROBLEM CODE WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE LEFT FEMORAL ARTERY VIA THE 14FR INTRODUCER TO SUPPORT THE 85 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE KNOWN CORONARY ARTERY DISEASE. ALL OTHER MEDICAL HISTORY WAS NOT SHARED. THE INSERTION AND DELIVERY OF THE CP TO THE LEFT VENTRICLE WAS NOT SUCCESSFUL. THE PATIENT HAD TORTUOSITY AND PREVIOUS ILIAC ARTERY STENTS THAT MAY HAVE CONTRIBUTED TO THE KINKING OF BOTH THE INTRODUCER SHEATH AND THE CP PUMP ITSELF. THE CP WAS EXPLANTED AND REPLACED DUE TO THE KINKING. THE PATIENT SURVIVED AND THE 2ND CP PUMP WAS PLACED FOR SUPPORT. A DELAY OF THERAPY INITIATION OCCURRED, HOWEVER THE EXCHANGE WAS PERFORMED WITH NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162896 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027860687 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1