BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24150460 · Received January 22, 2026

    Report

    Report Number
    1220648-2026-01316
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    January 12, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6B: ADDED EXPLANT DATE.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6 CODE E1906 AND E0509 WERE REMOVED DUE TO NEW INFORMATION RECEIVED. B5 WAS UPDATED WITH THE ADDITIONAL INFORMATION. THE INVESTIGATION WAS COMPLETED. INVESTIGATION SUMMARY: PERI-PROCEDURAL ADVERSE EVENT (ISCHEMIA, THROMBOSIS, INFECTION): THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: THE PATIENT IS A 63-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR PERIPHERAL ARTERY DISEASE (PAD) AND PERIPHERAL VASCULAR DISEASE (PVD). THE IMPELLA 5.5 (SN: (B)(6), (B)(4); GU CASE (B)(6) WAS SURGICALLY IMPLANTED VIA THE RIGHT AXILLARY/SUBCLAVIAN ARTERY ON (B)(6) 2026 AT 1:15 PM FOR HEMODYNAMIC SUPPORT IN THE SETTING OF POST-CARDIOTOMY CARDIOGENIC SHOCK AND LOW CARDIAC OUTPUT SYNDROME. ON (B)(6) 2026, THE PATIENT REMAINED ON V A ECMO AND IMPELLA SUPPORT UNTIL ECMO WEANING AND DECANNULATION OCCURRED AT APPROXIMATELY 4:30 PM. SHORTLY BEFORE MIDNIGHT THE SAME DAY, THE PATIENT LOST PULSES IN THE LEFT LEG¿PREVIOUSLY THE ECMO CANNULATION SITE. BIVALIRUDIN HAD BEEN PAUSED FOR DECANNULATION. THE PATIENT WAS URGENTLY TAKEN TO THE OPERATING ROOM FOR A LEFT LOWER-EXTREMITY THROMBECTOMY. THE PATIENT IS KNOWN TO HAVE SIGNIFICANT UNDERLYING VASCULAR DISEASE PRIOR TO MECHANICAL CIRCULATORY SUPPORT. ON (B)(6) 2026, THE CLINICAL TEAM REPORTED CONCERN FOR INFECTION DUE TO AN ELEVATED WBC OF 14; ANTIBIOTICS WERE INITIATED AND POTENTIALLY BROADENED. NO GROWTH HAS BEEN REPORTED FROM CULTURES, AND THE IMPELLA INSERTION SITE APPEARS CLEAN WITH NO SIGNS OF LOCAL INFECTION. THE DEVICE REMAINS IN SITU, AND THE PATIENT CONTINUES ON IMPELLA SUPPORT.

    Description of Event or Problem · 0

    UPDATED CLINICAL RATIONALE: THE PATIENT IS A (B)(6)YEAR-OLD MALE WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR PERIPHERAL ARTERY DISEASE (PAD) AND PERIPHERAL VASCULAR DISEASE (PVD). THE IMPELLA 5.5 (SN (B)(6); GU CASE 01568189) WAS SURGICALLY IMPLANTED VIA THE RIGHT AXILLARY/SUBCLAVIAN ARTERY ON (B)(6)2026 AT 1:15 PM FOR HEMODYNAMIC SUPPORT IN THE SETTING OF POST-CARDIOTOMY CARDIOGENIC SHOCK AND LOW CARDIAC OUTPUT SYNDROME. ON (B)(6)2026, THE PATIENT REMAINED ON V A ECMO AND IMPELLA SUPPORT UNTIL ECMO WEANING AND DECANNULATION OCCURRED AT APPROXIMATELY 4:30PM. SHORTLY BEFORE MIDNIGHT THE SAME DAY, THE PATIENT LOST PULSES IN THE LEFT LEG¿PREVIOUSLY THE ECMO CANNULATION SITE. BIVALIRUDIN HAD BEEN PAUSED FOR DECANNULATION. THE PATIENT WAS URGENTLY TAKEN TO THE OPERATING ROOM FOR A LEFT LOWER-EXTREMITY THROMBECTOMY. THE PATIENT IS KNOWN TO HAVE SIGNIFICANT UNDERLYING VASCULAR DISEASE PRIOR TO MECHANICAL CIRCULATORY SUPPORT. ON 1/14/2026, THE CLINICAL TEAM REPORTED CONCERN FOR INFECTION DUE TO AN ELEVATED WBC OF 14; ANTIBIOTICS WERE INITIATED AND POTENTIALLY BROADENED. NO GROWTH HAS BEEN REPORTED FROM CULTURES, AND THE IMPELLA INSERTION SITE APPEARS CLEAN WITH NO SIGNS OF LOCAL INFECTION. THE DEVICE REMAINS IN SITU, AND THE PATIENT CONTINUES ON IMPELLA SUPPORT. ADDITIONAL INFORMATION RECEIVED ON 06FEB2026 CONFIRMED THAT THE IMPELLA 5.5 PUMP (S/N (B)(6)) WAS NOT AVAILABLE FOR RETURN OR ANALYSIS, PER UPMC PRESBYTERIAN VAD ENGINEERS. REGARDING THE REPORTED FAILURE MODES: THE LIMB ISCHEMIA AND NEED FOR INTERVENTION WERE ATTRIBUTED TO THE ECMO LIMB AND NOT TO THE IMPELLA 5.5 DEVICE. THE SUSPECTED INFECTION WAS DETERMINED NOT TO BE RELATED TO THE IMPELLA INSERTION SITE. THE IMPELLA 5.5 WAS EXPLANTED ON (B)(6)2026, AND THE PATIENT SURVIVED THE HOSPITALIZATION. BASED ON THE AVAILABLE CLINICAL INFORMATION, THE REPORTED COMPLICATIONS OF LIMB ISCHEMIA AND POSSIBLE INFECTION WERE NOT ATTRIBUTED TO THE IMPELLA 5.5 DEVICE. THE ISCHEMIC EVENT WAS ASSOCIATED WITH THE PRIOR ECMO CANNULATION SITE IN THE SETTING OF UNDERLYING VASCULAR DISEASE, AND NO EVIDENCE INDICATED DEVICE-RELATED INFECTION. NO DEVICE MALFUNCTION WAS IDENTIFIED, AND THE PUMP WAS NOT AVAILABLE FOR RETURN ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213938 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026783005 813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention