BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23534691 · Received November 12, 2025

    Report

    Report Number
    1220648-2025-48314
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 12, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION ADDED FOR EXPLANTATION, PATIENT OUTCOME IS NOT AVAILABLE. D6B: EXPLANT DATE HAS BEEN ADDED. H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY: CLINICAL SYMPTOMS (STROKE/CVA): THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PUMP SUCTION: THE PUMP WAS NOT RETURNED FOR INVESTIGATION. DATA LOG WAS NOT PROVIDED FOR THE FIRST 6.5 HOURS OF THE CASE RUN ON 10-OCT, AND THE SUCTION ISSUE WAS REPORTED ON 22-OCT. THE CAUSE OF THE SUCTION ISSUE WAS NOT DETERMINED WITHOUT RETURNED PRODUCT INVESTIGATION AND SUFFICIENT CLINICAL DETAILS, INCLUDING DATA LOGS. DEVICE HISTORY LOT: DEVICE BATCH: 1955097. DEVICE HISTORY REVIEW: THE PUMP (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    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.

    Description of Event or Problem · 0

    THE DEVICE WAS EXPLANTED SUCCESSFULLY AFTER WEANING DURING SURGICAL IMPLANT OF A DURABLE LEFT ASSIST DEVICE. THE EXPLANT WAS NOT CONSIDERED PREMATURE AND WAS UNRELATED TO THE REPORTED COMPLICATION. PATIENT OUTCOME IS UNKNOWN AS OUTCOME INFORMATION WAS NOT AVAILABLE IN THE COMPLAINT RECORD ACCESSIBLE FOR MDR ASSESSMENT AT TIME OF REPORTING.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS ESCALATED TO AN IMPELLA 5.5 FROM AN IMPELLA CP DEVICE FOR INCREASED MECHANICAL CIRCULATORY SUPPORT. THE PATIENT WAS INITIALLY TRANSFERRED FROM AN OUTSIDE HOSPITAL IN CARDIOGENIC SHOCK. THE PATIENT WAS PLACED ON VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) SUPPORT. FOLLOWING SUCCESSFUL DECANNULATION FROM VA-ECMO EARLIER THE SAME WEEK, THE PATIENT EXPERIENCED RUNS OF ARRHYTHMIA AND WEAKENING PRESSURES, INCLUDING EPISODES OF COMPLETE HEART BLOCK THAT REQUIRED THE PLACEMENT OF A TEMPORARY PERMANENT PACEMAKER. DUE TO PERSISTENT INSTABILITY AND AN ONGOING REQUIREMENT FOR MECHANICAL CIRCULATORY SUPPORT, AN IMPELLA CP WAS IMPLANTED VIA THE RIGHT FEMORAL ARTERY. DURING IMPELLA CP SUPPORT, THE PUMP ALARMED FOR SUCTION AND AS A RESULT OF THE ALARMS THE PATIENT RECEIVED INTRAVENOUS FLUIDS. THE MEDICAL TEAM EVALUATED THE PATIENT¿S RIGHT ILIAC ARTERY FOR A POTENTIAL OCCLUSION. COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE PATIENT HAD A RIGHT ILIAC OCCLUSION, AND TO RESOLVE THE ISCHEMIA THE PATIENT HAD A FEMORAL-TO-FEMORAL BYPASS. IT WAS NOTED THAT THE PATIENT¿S LACTATE VALUES HAD INCREASED DUE TO THE PRIOR DECOMPENSATION EVENT. THE PATIENT REMAINED UNSTABLE ON THE IMPELLA CP AND THE CARE TEAM SUBSEQUENTLY ESCALATED TO AN IMPELLA 5.5 TO PROVIDE AN INCREASED LEVEL OF SUPPORT. THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LABORATORY, THE IMPELLA 5.5 WAS IMPLANTED AND THE IMPELLA CP WAS EXPLANTED WITH NO COMPLICATIONS. ON DAY FOUR OF IMPELLA 5.5 SUPPORT, IT WAS NOTED THAT THE PATIENT UNDERWENT A THROMBECTOMY OVER THE WEEKEND FOR A STROKE, WHICH YIELDED NEGATIVE RESULTS. ANTICOAGULATION THERAPY WAS WITHHELD. THE FOLLOWING DAY, THE PATIENT REMAINED OFF OF HEPARIN DUE TO HEPARIN INDUCED THROMBOCYTOPENIA. CT SCANS WERE CONDUCTED WITH NO CHANGES IN IMAGE FINDINGS. ON DAY SEVEN OF IMPELLA 5.5 SUPPORT, ANTICOAGULATION THERAPY WAS RESTARTED, AND THE PATIENT WAS GIVEN BIVALIRUDIN DUE TO THE PATIENT¿S HISTORY OF HEPARIN INDUCED THROMBOCYTOPENIA. THE PATIENT REMAINED ON SUPPORT WITH THE CARE PLAN TO REST AND RECOVER AND BRIDGE TO A DURABLE LEFT VENTRICULAR ASSIST DEVICE. ON DAY 13 OF IMPELLA 5.5 SUPPORT, THE IMPELLA EXPERIENCED SUCTION ALARMS AND THE PATIENT WAS ADMINISTERED ONE LITER OF ISOLYTE TO MANAGE VOLUME STATUS. THE PATIENT BEGAN WORKING WITH PHYSICAL THERAPY AND OCCUPATIONAL THERAPY IN A CHAIR. THERE WAS NO CHANGE IN THE IMPELLA CARE PLAN, AND NO ISSUES OR CONCERNS RELATED TO THE DEVICE WERE NOTED BY STAFF. AT THE TIME OF WRITING THIS REPORT, THE PATIENT CONTINUES TO BE SUPPORTED BY IMPELLA 5.5 WHILE AWAITING SURGERY FOR A DURABLE LEFT VENTRICULAR ASSIST DEVICE. THIS COMPLAINT INVOLVES TWO AUTOMATED IMPELLA DEVICES: PUMP 1: IMPELLA CP, WITH SERIAL NUMBER (B)(6) PUMP 2: IMPELLA 5.5, WITH SERIAL NUMBER (B)(6) THIS REPORT SPECIFICALLY ADDRESSES PUMP 2: IMPELLA 5.5, WITH SERIAL NUMBER (B)(6). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER DEVICE ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980734 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026717814 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention