BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24639300 · Received March 19, 2026

    Report

    Report Number
    1220648-2026-05635
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    December 1, 2025
    Report Date
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IMPELLA 5.5 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 IMPELLA CP.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D1 BRAND NAME UPDATED. D4 SERIAL NUMBER AND UDI UPDATED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DETERMINATION REQUIRING CORRECTION WAS MADE: ALL REPORTED COMPLAINT EVENTS DOCUMENTED IN THIS FILE THAT OCCURRED AFTER "IMPELLA 5.5 UNABLE TO PASS THROUGH LEFT AXILLARY ARTERY. COULD NOT ADVANCE TO THE DESCENT INTO THE AORTA." OCCURRED ON THE SUBSEQUENTLY IMPLANTED IMPELLA CP (RELATED COMPLAINT UPDATED ACCORDINGLY). CODING UPDATED TO REFLECT THE IMPELLA 5.5 ONLY. CODES ADDED: HEMODYNAMIC INSTABILITY (E2343). CODES REMOVED: RESUSCITATION (F2306), BLOOD TRANSFUSION (F2302), STROKE (E0133), CARDIOGENIC SHOCK (E233601), THROMBOCYTOPENIA (E030202), CARDIAC ARREST (E0602).

    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.

    Description of Event or Problem · 0

    66-YEAR-OLD MALE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFTING AND EXPERIENCED POST CARDIOTOMY CARDIOGENIC SHOCK. AN IMPELLA CP WAS IN PLACE AFTER SURGERY. THE PATIENT CARDIAC ARRESTED POST OPERATIVELY WITH CPR WITH SUCCESSFUL RETURN OF CIRCULATION. THE FOLLOWING DAY, THE PATIENT HAD VENTRICULAR TACHYCARDIA REQUIRING ANTIARRHYTHMIC MEDICATION. THE PATIENT WAS THROMBOCYTOPENIC REQUIRING PLATELET TRANSFUSION. ISSUES WITH PLACEMENT SIGNAL WERE NOTED HOWEVER, THE MD WAS ABLE TO REPOSITION WITH RETURN OF NORMAL WAVEFORMS. THE INOTROPIC AND VASOPRESSOR NEEDS CONTINUED. DUE TO HIS POOR NEURO STATUS, HE WAS TAKEN TO CT SCAN AND FOUND TO HAVE MULTIPLE INFARCTS. ON (B)(6) 2025 THERE WAS AN ATTEMPT TO UPGRADE THE CP TO A 5.5, HOWEVER, THEY WERE UNABLE TO PASS IT THROUGH THE LEFT AXILLARY ARTERY AND THEREFORE COULD NOT ADVANCE INTO THE AORTA. THE TEAM OPTED TO WITHDRAW CARE DUE TO PATIENT NEURO STATUS AND LACK OF PROGRESS. UNABLE TO ATTRIBUTE PATIENT OUTCOMES TO THE IMPELLA CP AS THE PATIENT WAS IN CARDIOGENIC SHOCK POST OPERATIVELY AND SUBSEQUENTLY CARDIAC ARRESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571988 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026636222 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1