BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25243123 · Received May 21, 2026

    Report

    Report Number
    1220648-2026-08085
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    May 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: A 33-YEAR-OLD MALE WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK (SCAI STAGE E) UNDERWENT IMPELLA SUPPORT VIA RIGHT FEMORAL PERCUTANEOUS ARTERIAL ACCESS. AT THE TIME OF EXPLANT ON (B)(6) 2026, IT WAS REPORTED THAT THE PRECLOSE SUTURES HAD BEEN INADVERTENTLY TIGHTENED PRIOR TO DEVICE REMOVAL. DURING EXPLANT, THE PUMP WAS WITHDRAWN TO THE REPOSITIONING SHEATH; HOWEVER, THE SHEATH WAS SUBSEQUENTLY PULLED OUT OF THE ARTERIOTOMY AND STOPPED AT THE MOTOR HOUSING, PREVENTING FURTHER REMOVAL OF THE IMPELLA CATHETER FROM THE ACCESS SITE. THE DEVICE COULD NOT BE ADVANCED OR WITHDRAWN THROUGH THE VASCULATURE, AND VASCULAR SURGERY WAS CONSULTED, RESULTING IN SURGICAL INTERVENTION WITH CUTDOWN FOR DEVICE REMOVAL. NO PRODUCT DAMAGE WAS REPORTED, NO EXCESSIVE FORCE WAS APPLIED, AND THE DEVICE WAS NOT REMOVED DUE TO A DEVICE-RELATED FAILURE MODE. THE PATIENT SURVIVED THE PROCEDURE AND WAS STABLE AT THE CONCLUSION OF THE EVENT. BASED ON INFORMATION PROVIDED, THE DIFFICULTY IN DEVICE REMOVAL APPEARS RELATED TO ACCESS SITE MANAGEMENT, SPECIFICALLY INADVERTENT PRE-TIGHTENING OF THE PRECLOSE SUTURES, AND NOT TO A MALFUNCTION OR PERFORMANCE ISSUE OF THE IMPELLA DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106001 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027859083 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention