BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 SMARTASSIST S2 SET, JP

    MDR report key: 24568461 · Received March 11, 2026

    Report

    Report Number
    1220648-2026-05024
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    March 7, 2026
    Report Date
    March 30, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    COMPLAINT CODING WAS CORRECTED, UPDATED TO BETTER REFLECT THE REPORTED EVENT. DECREASE IN PRESSURE (A141101) WAS REMOVED. AS A RESULT, THE H6 HEALTH EFFECT ¿ CLINICAL/IMPACT AND MEDICAL DEVICE PROBLEM CODING HAVE BEEN FULLY UPDATED AND SHOULD BE CONSIDERED THE REPRESENTATION OF THE REPORTED EVENT. PRODUCT STATUS. THE IMPELLA DEVICE HAS BEEN RECEIVED, AND EVALUATION/ANALYSIS IS CURRENTLY IN PROGRESS. ACCORDINGLY, SECTION D9 HAS BEEN UPDATED TO REFLECT THE DEVICE RECEIPT DATE. SECTION H6 (INVESTIGATION TYPE, FINDINGS, AND CONCLUSION) HAS ALSO BEEN UPDATED TO ALIGN WITH THIS INFORMATION. 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

    THE COMPLAINANT REPORTED THAT THE PATIENT WAS IN CUSTODY AND THAT PURGE FLUID WAS LEAKING FROM THE AREA NEAR THE CHAMBER. THERE WAS NO LOW-PRESSURE PURGE ALARM, BUT CRYSTALIZED RESIDUE WAS OBSERVED FALLING TO THE FLOOR, PROMPTING THEM TO CONTACT US. THE ATTENDING PHYSICIAN WILL BE INFORMED, AND FOLLOW-UP WILL BE PERFORMED AS DEVICE REMOVAL IS ALREADY PLANNED.

    Description of Event or Problem · 0

    A 66 YEAR OLD MALE WAS ESCALATED FROM IMPELLA CP TO IMPELLA 5.5 SUPPORT FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE 5.5 WAS INSERTED VIA RIGHT AXILLARY/SUBCLAVIAN ARTERY. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE A. ON DAY 16 OF SUPPORT, WHILE IN THE INTENSIVE CARE UNIT, THERE WAS A CONFIRMED LEAK OF PURGE FLUID FROM THE PRESSURE RESERVOIR INSIDE THE SIDE ARM RETAINER. PURGE PRESSURE DID NOT DECREASE AND THERE WAS NO ALARM, BUT IT IS REPORTED THAT CRYSTALS WERE FALLING ON THE FLOOR. NO ACTION WAS TAKEN TO ADDRESS THE LEAKING PURGE SOLUTION. THE PATIENT'S CARDIAC FUNCTION HAD RECOVERED AND DEVICE REMOVAL WAS SCHEDULED. THE REMOVAL WAS PLANNED AND UNRELATED TO THIS LEAK. THE FLUID LEAK WILL BE REPORTED, HOWEVER THERE WAS NO CONSEQUENCE TO THE PATIENT AND SUPPORT. TWO DAYS LATER, DURING THE 5.5 REMOVAL, CALCIFICATION WAS FOUND IN THE SUBCLAVIAN ARTERY AND PREVENTED ITS REMOVAL. A SHEATH AND WIRE WERE USED TO REMOVE THE 5.5, BUT THE WIRE BECAME CAUGHT ON THE CALCIFIED AREA AND CAUSED VASCULAR DAMAGE. BLEEDING OCCURRED AND HEMOSTASIS WAS ACHIEVED, BUT BLEEDING RECURRED AND REQUIRED A STENT GRAFT TO BE PLACED. ATTENDING PHYSICIANS STATED THAT THERE WERE NO PROBLEMS WITH THE PATIENT'S PROGNOSIS AND THAT THE INCIDENT WAS NOT RELATED TO IMPELLA. THE REPORTED BLEEDING IS CONSERVATIVELY REPORTED AS IT MAY OCCUR IN THE SETTING OF IMPELLA 5.5 SUPPORT, HOWEVER THE IMPLANT WAS SUCCESSFULLY EXPLANTED AND THE PHYSICIANS DID NOT ATTRIBUTE THE BLEED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550299 IMPELLA 5.5 SMARTASSIST S2 SET, JP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026815702

    Patients

    Seq Age Sex Outcome Treatment
    1