BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24818395 · Received April 8, 2026

    Report

    Report Number
    1220648-2026-06527
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 31, 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
    SC, 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

    MAJOR BLEED/PATIENT-DEVICE INTERACTION/USE AGAINST LABELLING: THE CAUSE OF THE ISSUE WAS LIKELY REASONABLE FORESEEABLE MISUSE AS CLINICAL INFORMATION MENTIONED CP REPOSITIONING SHEATH WAS IN TAVR SHEATH CAUSING BLEEDING.

    Additional Manufacturer Narrative · 0

    SECTION D MEDICAL DEVICE HAS BEEN UPDATED. H6 HEALTH EFFECT - IMPACT CODE F2302 HAS BEEN UPDATED TO F2303 H6 MEDICAL DEVICE PROBLEM CODE A24 HAS BEEN UPDATED TO A01

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY AND THE TAVR SHEATH. THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) SHEATH DIAMETER WAS NOT SHARED. THE 71 YEAR OLD MALE PATIENT HAD THE TAVR AND CP PLACED INDEPENDENT OF AN PRESENT IMPELLA FIELD REPRESENTATIVE. THE FOLLOWING DAY THE TEAM NOTED THE CP REPOSITIONING SHEATH WAS IN THE TAVR SHEATH AND WAS BLEEDING. THE PATIENT WAS GIVEN 3 UNITS OF BLOOD TO REMEDY THE ISSUE. THE PUMP WAS EXPLANTED AFTER UNDER 1 DAY OF SUPPORT. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING, AS CAN THE OFF-LABEL USE OF A NON-ABIOMED INTRODUCER SHEATH. THE PATIENT DID SURVIVE THE BLOOD LOSS AND PUMP EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90558 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027858243 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1