BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24844202 · Received April 10, 2026

    Report

    Report Number
    1220648-2026-06600
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    April 4, 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
    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

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX), D10 (CONCOMITANT PRODUCT), E1 (INITIAL REPORTER STATE, ZIP CODE EXTENSION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (SERIAL, PRIMARY UDI NUMBER). UPON REVIEW, THE SECTION D PRIMARY UDI NUMBER HAVE NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN E3 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D9, H3, H6, AND H11. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE HEMOLYSIS ISSUE WAS MOST LIKELY RELATED TO UNINTENDED USE, SINCE IT WAS FOUND DEEP DURING THE TIME OF HEMOLYSIS. THE CAUSE OF THE POSITIONING ISSUE WAS NOT DETERMINED WITHOUT SUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: A 77-YEAR-OLD MALE UNDERWENT HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) WITH IMPELLA SUPPORT VIA RIGHT FEMORAL ARTERIAL PERCUTANEOUS ACCESS ON (B)(6) 2026 AT 10:20 AM. THE PATIENT¿S PRE-SUPPORT CLINICAL STATUS WAS CONSISTENT WITH SCAI SHOCK STAGE E. DURING IMPELLA SUPPORT, THE CUSTOMER REPORTED A PS LOW ALARM ACCOMPANIED BY LABORATORY EVIDENCE OF HEMOLYSIS, WITH PLASMA FREE HEMOGLOBIN (PFHGB) INCREASING FROM 0 TO 85 MG/DL WITHIN APPROXIMATELY 24 HOURS AND ASSOCIATED GROSS HEMATURIA. FURTHER EVALUATION IDENTIFIED THAT THE PIGTAIL WAS CONTACTING THE MITRAL VALVE APPARATUS, AND REPOSITIONING ATTEMPTS WERE UNSUCCESSFUL DUE TO THE PIGTAIL BEING CAUGHT IN THE MITRAL VALVE. AS THE POSITIONING ISSUE COULD NOT BE RESOLVED, THE IMPELLA DEVICE WAS REMOVED ON (B)(6) 2026 AT 5:24 PM AND REPLACED WITH AN INTRA-AORTIC BALLOON PUMP (IABP). THE PATIENT SURVIVED THE PROCEDURE AND WAS REPORTED TO BE STABLE AT EXPLANT. BASED ON THE AVAILABLE INFORMATION, THIS CASE REPORTS HEMOLYSIS DURING IMPELLA SUPPORT, ASSOCIATED WITH CONFIRMED CONTACT BETWEEN THE PUMP PIGTAIL AND THE MITRAL VALVE APPARATUS, NECESSITATING DEVICE REMOVAL AND TRANSITION TO IABP SUPPORT; THE PATIENT SURVIVED AND REMAINED STABLE FOLLOWING EXPLANT. HEMOLYSIS MAY BE INFLUENCED BY PATIENT SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, RENAL FUNCTION, ANTICOAGULATION STATUS, AND POTENTIAL DEVICE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906581 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027843918 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention INTRA-AORTIC BALLOON PUMP