BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24607477 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05347
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    October 2, 2025
    Report Date
    April 25, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D1 BRAND NAME UPDATED. H6 COMPONENT CODE CHANGED TO G07003. THE INVESTIGATION FOR THE SEPSIS/RENAL FAILURE/TACHYCARDIA/THROMBOCYTOPENIA HAS BEEN COMPLETED. THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE INVESTIGATION FOR THE MINOR BLEED HAS BEEN COMPLETED. THE ROOT CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    A-PATIENT DEMOGRAPHIC UPDATED. D1, D2B, D4, D6A, D6B, G4, AND H4 UPDATED WITH PRODUCT INFORMATION.

    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

    A 79 YEAR OLD FEMALE WITH A MEDICAL HISTORY OF DIABETES, A TRANSIENT ISCHEMIC ATTACK, CHRONIC KIDNEY DISEASE, PULMONARY EMBOLISM AND CORONARY ARTERY DISEASE INCLUDING A PREVIOUS MYOCARDIAL INFARCTION LEADING TO ISCHEMIC CARDIOMYOPATHY. SHE PRESENTED WITH CONCERNS OF A RAPID HEART RATE. BEFORE INTERVENTION COULD BE PERFORMED, THE PATIENT BECAME HYPOTENSIVE AND HYPOXIC REQUIRING INTUBATION. IN THE CATHETERIZATION LABORATORY, AN IMPELLA CP WAS PLACED AND A PERCUTANEOUS CORONARY INTERVENTION CARRIED OUT. AS THE PATIENT CONTINUED TO DETERIORATE, THE PROCEDURE HAD TO BE ABORTED AND THE PATIENT WASS TRANSFERRED TO A HIGHER CARE LEVEL. WHILE ROUNDING ON THE PATIENT, THE AORTIC PLACEMENT SIGNAL DISAPPEARED, SHORTLY AFTER, A ¿CONTROLLER ERROR¿ ALARM POPPED UP AND THE CONTROLLER HAD TO BE EXCHANGED. SOME SLIGHT OOZING AT THE GROIN ACCESS WAS NOTED MANAGED BY A DRESSING CHANGE. THE PATIENT DEVELOPED SIGNS OF SEPSIS, BLOOD CULTURES LATER CONFIRMED TO BE POSITIVE FOR YEAST WITH A PREVIOUSLY KNOWN YEAST INFECTION OF THE GROINS. THE PATIENT WAS STARTED ON ANTIBIOTIC TREATMENT AS WELL AS CONTINUOUS RENAL REPLACEMENT THERAPY DUE TO RENAL FAILURE. ON THE NEXT DAY, THE PATIENT SHOWED SIGNS OF GASTRO-INTESTINAL BLEEDING THAT DID NOT REQUIRE INTERVENTION AND DECOMPENSATED DURING A DEVICE WEANING TRIAL, LEADING TO SUPRAVENTRICULAR THEN VENTRICULAR TACHYCARDIA REQUIRING DEFIBRILLATION. POSITION OF THE IMPELLA PUMP WAS RECONFIRMED WITH BOTH ECHOCARDIOGRAPHY AND FLUOROSCOPY WITHOUT NEED FOR REPOSITIONING. OVER THE NEXT DAYS, THE PATIENT DEVELOPED A THROMBOCYTOPENIA AND SYSTEMIC HEPARIN WAS HALTED WHILE HEPARIN INDUCED THROMBOCYTOPENIA COULD BE RULED OUT. AFTER 5 DAYS OF SUPPORT, THE PATIENT WAS SUCCESSFULLY WEANED AND THE IMPELLA CP REMOVED. COMPLICATIONS WILL BE CODED TO THE IMPELLA CP, AS - WHILE PRESUMABLY HEAVILY RELATED TO PRE-EXISTING DISEASE (YEAST INFECTION OF THE GROIN, RENAL FAILURE BASED ON CHRONIC KIDNEY DISEASE, PROCEDURAL APPLICATION OF CONTRAST AGENT AND SHOCK-INDUCED ORGAN HYPOPERFUSION) - AN ASSOCIATION TO THE DEVICE CANNOT BE FULLY RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364735 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026712937 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1