BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24895503 · Received April 16, 2026

    Report

    Report Number
    1220648-2026-06875
    Event Type
    Death
    Date Received
    April 16, 2026
    Date of Event
    April 13, 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
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D9; H3. THE CAUSE OF THE ISSUE WAS MOST LIKELY RELATED TO USE OF THE DEVICE, SINCE THE CLINICAL DETAILS MENTION A POSITIONING ISSUE OCCURRING DURING THE PEEL-AWAY SHEATH EXCHANGE, WHICH LED TO DEVICE REPOSITIONING. EVIDENCE OF KINK PRESENT ON THE RETURNED PUMP, WHICH WAS ONE OF THE SIGNS OF THE DEVICE BEING IN THE WRONG POSITION. THE CAUSE OF THE LOW PUMP FLOW ISSUE WAS RELATED TO A KINK OF THE DEVICE, MOST LIKELY DUE TO AN UNINTENDED USE-RELATED ISSUE, SINCE IMPROPER POSITION LED TO THE DEVICE BEING REPOSITIONED, AND AT THAT TIME, A KINK WAS OBSERVED ON THE PUMP. THE 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. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA CP DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE GUIDEWIRE.

    Additional Manufacturer Narrative · 0

    D4 REVISED. H6 MEDICAL DEVICE PROBLEM CODE A140508 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 74-YEAR-OLD MALE PATIENT FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E SHOCK. DURING IMPLANTATION, DIFFICULTY CROSSING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) VALVE WITH THE PIGTAIL AND 0.018-INCH GUIDEWIRE WAS REPORTED. DESPITE THIS, THE IMPELLA CP WAS SUCCESSFULLY ADVANCED OVER THE WIRE WITHOUT ISSUE, AND THE PUMP INITIALLY FUNCTIONED WITHOUT CONCERNS. DURING A SUBSEQUENT PEEL-AWAY SHEATH EXCHANGE PERFORMED BY THE PHYSICIAN AND SCRUB TEAM, THE PUMP WAS OBSERVED TO BE PULLED BACKWARDS. ATTEMPTS TO RE-ADVANCE THE DEVICE INTO THE LEFT VENTRICLE (LV) WERE UNSUCCESSFUL DUE TO A KINK IDENTIFIED IN THE CANNULA JUST BELOW THE MOTOR HOUSING. AT THAT TIME, FLOWS WERE REDUCED TO APPROXIMATELY 2.1 L/MIN. BASED ON THESE FINDINGS, THE CLINICAL TEAM ELECTED TO REMOVE THE AFFECTED IMPELLA CP AND REPLACE IT WITH A NEW IMPELLA CP. NO ADVERSE EVENTS WERE REPORTED WITH THE SECOND IMPELLA CP. THE PATIENT ULTIMATELY EXPIRED. THE SURVIVAL OUTCOME WAS DEATH, WHICH IS BEING CONSERVATIVELY REPORTED AND CODED TO THE FIRST IMPELLA CP. HOWEVER, BASED ON THE AVAILABLE CLINICAL INFORMATION, THE DEATH IS MORE LIKELY ATTRIBUTABLE TO THE PATIENT¿S UNDERLYING CRITICAL CONDITION, INCLUDING SEVERE AMI/CGS AND SCAI STAGE E CARDIOGENIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298274 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027847739 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1