BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICAL, AIC, IMPELLA CONNECT, PKGD, US

    MDR report key: 24511526 · Received March 4, 2026

    Report

    Report Number
    1220648-2026-04449
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    February 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011401
    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

    B5. ADDITIONAL EVENT DESCRIPTION INADVERTENTLY LEFT OUT FROM THE PREVIOUS REPORT ADDED. D1. BRAND NAME CORRECTED. D9 IS DEVICE RETURNED TO MANUFACTURER? AND DATE DEVICE RETURNED TO MANUFACTURER ADDED. H6. MEDICAL DEVICE PROBLEM CODE ADDED.

    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

    B1 PRODUCT PROBLEM WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT. D6A AND D6B SHOULD HAVE BEEN LEFT BLANK.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED A CALL WAS RECEIVED REGARDING A PLACEMENT SIGNAL UNRELIABLE ALARM. TEAM STATES THAT PATIENT WAS CONFUSED AND GOT OUT OF BED WITHOUT ASSISTANCE. HE WAS FOUND WITH THE IMPELLA ON THE UPPER RIGHT SIDE OF THE BED AND PATIENT ON THE LEFT SIDE OF THE BED ATTEMPTING TO AMBULATE TO THE BATHROOM WITH THE IMPELLA REPORTEDLY TUGGED ON, WRAPPED AROUND HIS LEG AND PULLED TAUNT. IMPELLA WAS ALARMING PLACEMENT SIGNAL UNRELIABLE WITH DROP OF BP. EPI PUSH GIVEN WITH IMPROVEMENT IN BP. PATIENT ASSISTED BACK TO BED AND TTE REVEALED IMPELLA ACROSS AV HOWEVER INLET CAGE APPEARED TO BE SHALLOW NEAR AV ANNULUS. CM MARKING REMAINED @ 47CM ON DEVICE AND 3 POINT FIXATION REMAINED. CTS REPOSITIONED DEVICE ADVANCING 3CM AND REOPTIMIZING TRAJECTORY THEN PULLING BACK WITH FINAL POSITION REMAINING AT 47CM WITH SATISFACTORY POSITION. PSNR REMAINED ACTIVE, NO KINKS NOTED. INSTRUCTED TO PUSH ON IMPELLA CABLE PLUG CONNECTION TO AIC. APPROPRIATE WAVEFORMS IMMEDIATELY RESUMED WITH RESOLUTION OF THE ALARM. NO FURTHER IMPELLA RELATED ALARMS OR POSITION ISSUES.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 WAS INSERTED VIA THE AXILLARY GRAFT SITE TO SUPPORT THE 64 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF CARDIOMYOPATHY AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. PRIOR TO THE 5.5 PLACEMENT THE PATIENT WAS ON AN INTRA-AORTIC BALLOON PUMP, INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. THE PATIENT HAD A PRIOR CARDIAC ARREST WITH CPR, BUT ANY OTHER UNDERLYING MEDICAL HISTORY AND COMORBIDITIES WERE NOT SHARED. AFTER 13 DAYS OF SUPPORT THE PUMP LOST THE APPROPRIATE PLACEMENT SIGNAL. THE PATIENT HAD BECOME CONFUSED AND GOTTEN HIMSELF UP OUT OF THE BED AND PULLED THE PUMP AND CORD, WHICH BECAME WRAPPED AND PULLED TAUGHT. THE PUMP WAS MALPOSITIONED AND WAS REPOSITIONED. THE PATIENT SUFFERED SOME HYPOTENSION DURING THIS TIME AND WAS GIVE A PUSH OF EPINEPHRINE. THE PUMP REPOSITIONING WAS SUCCESSFUL AND THE CORD AND PLUG WERE REVIEWED AND SIGNAL RETURNED. THE PUMP REMAINED ON FOR SUPPORT BUT, AFTER 16 DAYS OF SUPPORT THERE WAS A MALFUNCTION IN WHICH THE PURGE CASSETTE WAS NOT RECOGNIZED. THE TEAM TROUBLESHOT BY REPLACEMENT OF THE CONTROLLER AND SUPPORT PROCEEDED AND REMAINS ON TO DATE. THE CONTROLLER REPLACEMENT WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION DURING THE EXCHANGE, HOWEVER THE EXCHANGE WAS PERFORMED WITH NO CONSEQUENCE TO THE PATIENT AND SUPPORT. THE HARM OF THE HYPOTENSION IS ALSO BEING REPORTED, THOUGH THE PATIENT HAD NO LASTING HARM REPORTED AND THE PUMP IS BEING UTILIZED WELL BEYOND THE INDICATED USE TIMELINE. ADDITIONALLY, THE HARM OCCURRED AFTER THE USER CAUSED PUMP MALPOSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626601 OPTICAL, AIC, IMPELLA CONNECT, PKGD, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1885740 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1