BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25186746 · Received May 15, 2026

    Report

    Report Number
    1220648-2026-07914
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    May 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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. H10: ADDED RELATED DEVICE REPORT NUMBER. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT 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

    US CLINICAL NARRATIVE: IMPELLA CP WAS INSERTED VIA RIGHT FEMORAL ARTERY IN A PATIENT OF 68-YEAR-OLD FEMALE FOR AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK (AMI/CGS) INDICATION. THE PATIENT¿S COMORBIDITIES INCLUDED PERIPHERAL ARTERIAL DISEASE WITH PRIOR RIGHT COMMON FEMORAL ARTERY REPAIR AND COVERED STENTS. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS, SCAI SHOCK STAGE E. FOLLOWING DEVICE PLACEMENT IN THE PREVIOUSLY STENTED RIGHT COMMON FEMORAL ARTERY, THE PATIENT¿S RIGHT LOWER EXTREMITY WAS NOTED TO BE MOTTLED, COOL, AND WITH PURPLE DISCOLORATION, CONCERNING FOR COMPROMISED PERFUSION. THE ACCESS SITE SELECTION UTILIZING A PREVIOUSLY STENTED VESSEL IN THE SETTING OF KNOWN PERIPHERAL VASCULAR DISEASE WAS NOTED. TROUBLESHOOTING INCLUDED REMOVAL OF THE IMPELLA CP AND ESCALATION OF SUPPORT TO AN IMPELLA 5.5 VIA RIGHT AXILLARY ARTERY. NO LABORATORY VALUES OR ADDITIONAL DIAGNOSTIC TEST RESULTS WERE PROVIDED. THE OBSERVED LIMB FINDINGS ARE MORE LIKELY RELATED TO VASCULAR ACCESS CONSIDERATIONS AND UNDERLYING PERIPHERAL VASCULAR DISEASE RATHER THAN DEVICE PERFORMANCE. THE POST-PROCEDURE OUTCOME WAS PATIENT SURVIVAL FOLLOWING ESCALATION TO IMPELLA 5.5 SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319140 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027860085 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1