BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24279268 · Received February 6, 2026

    Report

    Report Number
    1220648-2026-02453
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    December 4, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PPAE/PERIPHERAL ARTERY DISSECTION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN B5 (EVENT DESCRIPTION). 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.

    Description of Event or Problem · 0

    A 78-YEAR-OLD MALE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ACUTE MYOCARDIAL INFARCTION CARDIOGENIC SHOCK UNDER CARDIOPULMONARY RESUSCITATION WITH A MEAN ATRIAL PRESSURE OF 62 MMHG (UNDER MORE THAN 3 CATECHOLAMINES AND RESPIRATORY SUPPORT) WITH A LEFT VENTRICULAR EJECTION FRACTION OF 20 MMHG, IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE E. HE HAD A KNOWN HISTORY OF CORONARY ARTERY DISEASE AND RENAL INSUFFICIENCY AND WAS ON INTRA-AORTIC BALLOON PUMP PRIOR TO IMPELLA CP SUPPORT. ACTIVATED CLOTTING TIME PRIOR TO THE IMPELLA CP DEVICE WAS 298 SECONDS. IMPELLA CP WAS PLACED FOR HEMODYNAMIC SUPPORT AND PATIENT TRANSFERRED TO THE INTENSIVE CARE UNIT ON HIGHEST IMPELLA PERFORMANCE LEVEL 9. WEANING OF MEDICATION WAS ONGOING AND REPOSITIONING OF THE DEVICE BY BEST PRACTICES WAS PERFORMED. CONTINUOUS RENAL REPLACEMENT THERAPY WAS RE-INITIATED AND WELL TOLERATED. SURGERY OF MITRAL, TRICUSPID VALVE AND CORONARY ARTERY BYPASS GRAFTING IN ADDITION TO A MAZE PROCEDURE WERE STILL PENDING. ON THE SECOND DAY OF IMPELLA CP SUPPORT, THE LEFT MAIN AND LEFT ANTERIOR DESCENDING WERE STENTED AS PLANNED AND THE LEFT CIRCUMFLEX ARTERY BALLOONED. AFTER THAT, PATIENT SUFFERED FROM ATRIAL FIBRILLATION, VASOPRESSORS HAD TO BE INCREASED AND LACTATE TRENDED UP. AFTERWARDS, AN ESCALATION TO IMPELLA 5.5 WAS PREPARED IN THE OPERATION ROOM AND A RIGHT AXILLARY ARTERY DISSECTION WAS SEEN UNDER FLUOROSCOPIC GUIDANCE BEFORE IMPELLA 5.5 INSERTION. THE DISSECTION COULD BE REPAIRED WITH A BALLOON AND IMPELLA 5.5 ADVANCED WITHOUT COMPLICATIONS THEREAFTER. ON THE SECOND DAY OF IMPELLA 5.5 SUPPORT, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND FINALLY SUCCESSFULLY WEANED ON DAY 3. THE IMPELLA CP IS CODED NOT FOR RENAL FAILURE OR ATRIAL FIBRILLATION AS THESE WERE PRE-EXISTENT. THE IMPELLA 5.5 GUIDE WIRE IS CODED FOR VASCULAR DISSECTION, WHICH IS RELATED TO THE PLANNED DEVICE INSERTION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTING "NOTED RIGHT AXILLARY ARTERY DISSECTION ON FLURO BEFORE 5.5 INSERTION. MUSTANG COVER BALLOON, AND IMPELLA ADVANCED WITHOUT COMPLICATIONS AFTER THAT."

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT A "MUSTANG COVER BALLON WAS USED AND SUSPECTED DISSECTION WAS RESOLVED IMMEDIATELY WITHOUT ANY FURTHER INTERVENTION. PT WAS SUCCESSFULLY WEANED AND RECOVERED. WE DO NOT HAVE PUMP AVAILABLE FOR RETURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278078 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US 2025571160 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1