BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24679890 · Received March 24, 2026

    Report

    Report Number
    1220648-2026-05841
    Event Type
    Death
    Date Received
    March 24, 2026
    Date of Event
    March 15, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011678
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    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

    REMOVE H6. HEALTH EFFECT - IMPACT CODE F19 FOR SURGICAL INTERVENTION; INADVERTENTLY REPORTED ON INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    B2 DEATH AND DATE AND DEATH UPDATED. THE EXACT DATE OF DEATH IS UNKNOWN BUT HAS BEEN CAPTURED AS THE DATE OF EXPLANT. IF ADDITIONAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. B5 UPDATED TO INCLUDE ADDITIONAL INFORMATION. H6 HEALTH EFFECT - IMPACT CODE F02 ADDED. H6 HEALTH EFFECT - CLINICAL CODE E0509 ISCHEMIA OMITTED.

    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. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN AN 87-YEAR-OLD FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE C SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE PEEL-AWAY SHEATH WAS LEFT IN PLACE BY THE PHYSICIAN. A RUN-OFF ANGIOGRAM WAS PERFORMED PRIOR TO LEAVING THE CATH LAB TO CONFIRM FLOW TO THE RIGHT LOWER EXTREMITY. A DISTAL PERFUSION CATHETER WAS PLACED. A STABLE HEMATOMA WAS NOTED AT THE ACCESS SITE. SIX DAYS AFTER IMPELLA INSERTION, THE FAMILY WITHDREW CARE, AND THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P-4 AT 2.6L/MIN AS INTENDED. LIMB ISCHEMIA CAN BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, ANTICOAGULATION STATUS, VASOPRESSOR SUPPORT, AND VASCULAR ACCESS CHARACTERISTICS. BLEEDING (HEMATOMA) IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS. THE IMPELLA IS CONSERVATIVELY BEING REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT IN ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, COMPLICATED BY STAGE C SHOCK.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 87-YEAR-OLD FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE C SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE PEEL-AWAY SHEATH WAS LEFT IN PLACE BY THE PHYSICIAN. A RUN-OFF ANGIOGRAM WAS PERFORMED PRIOR TO LEAVING THE CATH LAB TO CONFIRM FLOW TO THE RIGHT LOWER EXTREMITY. THE PATIENT DID NOT HAVE LEG ISCHEMIA AS THE PATIENT HAD A DISTAL PERFUSION CATHETER THAT WAS PLACED PROPHYLACTICALLY TO MITIGATE LIMB ISCHEMIA DUE TO THE PEEL-AWAY SHEATH BEING LEFT IN PLACE. A STABLE HEMATOMA WAS NOTED AT THE ACCESS SITE. SIX DAYS AFTER IMPELLA INSERTION, THE FAMILY WITHDREW CARE, AND THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P-4 AT 2.6L/MIN AS INTENDED. BLEEDING (HEMATOMA) IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS. THE DEATH IS CONSERVATIVELY BEING REPORTED; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT IN ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, COMPLICATED BY STAGE C SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26992 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 S9956351 00813502011678

    Patients

    Seq Age Sex Outcome Treatment
    1