BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24601589 · Received March 15, 2026

    Report

    Report Number
    1220648-2026-05278
    Event Type
    Injury
    Date Received
    March 15, 2026
    Date of Event
    November 11, 2025
    Report Date
    March 29, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA. B3 AND D1 CORRECTED/UPDATED.

    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

    63 YEAR OLD MALE PATIENT TREATED WITH IMPELLA CP AND LATER ESCALATED TO IMPELLA 5.5 DUE TO ACUTE MYOCARDIAL INFARCTION. PATIENT ARRIVED AS NSTEMI, PATIENT PLANNED FOR HIGH RISK PERCUTANEOUS CORONARY INTERVENTION WITH IMPELLA SUPPORT FOR THE NEXT DAY. PATIENT THEN DEVELOPED ST CHANGES AND BROUGHT TO CATHETER LAB FOR URGENTLY FOR IMPELLA PLACEMENT. SUCCESSFUL PLACEMENT OF IMPELLA VIA RIGHT FEMORAL ARTERY. VASCULAR SURGEON CAME IN TO PERFORM ANGIOPLASTY PERFORMED PRIOR TO 14 FR SHEATH OF RIGHT ILIAC - CODED HERE FOR DUE TO COMPLEXITY OF THE REVASCULARIZATION THE CARDIOVASCULAR SURGEON ON CALL WAS CONSULTED, WITH REDO AND LOW EJECTION FRACTION TOO HIGH RISK FOR A EMERGENT CORONARY ARTERY BYPASS GRAFTING. DECISION WAS MADE TO TRANSFER PATIENT TO A DIFFERENT HOSPITAL. DURING LOADING INTO AIRCRAFT CUT THE TUBING LINE ON ACCIDENT FROM THE PURGE SOLUTION. CALLED AND DISCONNECTED LONG PORTION OF PURGE TUBING AND CONNECTED YELLOW PORT FOR 5.5 PURGE SOLUTION WHILE A REPLACEMENT PURGE CASSETTE WAS BROUGHT TO THE AIRPORT. PATIENT WAS LOADED ONTO AIRCRAFT WITH NEW TUBING AND TRANSFERRED TO NEW FACILITY WITHOUT ISSUES. NO HARM TO THE PATIENT AND CONTINUED SUPPORT WAS NEVER INTERRUPTED. PEEL AWAY SHEATH WAS STILL IN PLACE AND THE BLUE HUB NOT SUTURED DOWN UPON ARRIVAL AT NEW SITE AND IMPELLA FOUND TO BE SHALLOW IN LEFT VENTRICLE. PUMP REPOSITIONED AT BEDSIDE BUT IMPELLA FACING LATERAL WALL SO DIFFICULT TO ADVANCE. IMPELLA POSITION NOT ACCORDING TO RECOMMENDATION IN INSTRUCTIONS FOR USE LEFT AT 2 CM IN LEFT VENTRICLE, BUT URINE OUTPUT WAS CLEAR TO YELLOW SO NO FURTHER ATTEMPTS TO REPOSITION WAS MADE AT THIS POINT. BLUE HUB SUTURED TO LEG AND SITE RE-DRESSED. DISTAL PULSES ON LEG FAINT BUT STILL PRESENT. PATIENT VERY UNCOMFORTABLE IN BED AND ANOTHER REPOSITIONING AND SWAN GANZ CATHETER INSERTION IN CATH LAB. TWO DAYS AFTER SUPPORT START WITH IMPELLA CP, PATIENT WAS ESCALATED TO IMPELLA 5.5, PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND HAD TO BE PUT BACK ON FURTHER MEDICAL SUPPORT WITH VASOPRESSORS - CODED FOR TACHYCARDIA AND MEDICATION REQUIRED. PATIENT REMAINS CRITICALLY ILL BUT STABLE ON IMPELLA SUPPORT. LABS SHOWED ELEVATED LDH AND PFHGB BUT CONTRIBUTING THAT TO CARDIOPULMONARY RESUSCITATION AND VASCULAR REPAIR. TO BE SAFE, POCUS COMPLETED AND SHOWED PUMP IN GOOD AND SHALLOW POSITION WITH INLET FREE IN THE MID LEFT VENTRICULAR SPACE. CODED HERE CONSERVATIVELY FOR HEMOLYSIS AND SERIOUS INJURY EVEN THOUGH ABOVE REASONS ARE CONTRIBUTING FACTORS TO HIGHER VALUES IN LACTATE DEHYDROGENASE ISOENZYME. PATIENT BEING PREPARED FOR DURABLE LEFT VENTRICULAR ASSIST DEVICE AND RECEIVING PACKED RED BLOOD CELLS FOR HGB 7.2. PATIENT SUCCESSFULLY BRIDGED TO DURABLE LVAD. DURING LOADING INTO AN AIRCRAFT FOR TRANSPORT, THERE WAS DAMAGE TO THE PURGE CASSETTE DURING IMPELLA CP SUPPORT. THE PURGE EXTENSION TUBING WAS CUT. THE DAMAGED EXTENSION TUBING WAS DISCONNECTED AND THE PURGE TUBING'S PROXIMAL YELLOW LUER WAS CONNECTED DIRECTLY TO THE CHECK VALVE ON THE IMPELLA CP. THE PATIENT'S SUPPORT CONTINUED WITH THIS TEMPORARY RESOLUTION WHILE WAITING FOR A REPLACEMENT PURGE CASSETTE TO BE BROUGHT TO THE AIRPORT. THE INFORMATION AVAILABLE INDICATES THAT THE FLIGHT CREW ONLY TOOK THE EXTENSION TUBE FROM THE NEW PURGE CASSETTE TO EXTEND THE EXISTING PURGE LINE, AS IT WAS NOTED THAT PATIENT SUPPORT WAS NEVER INTERRUPTED. AN ABIOMED REPRESENTATIVE GUIDED THE MEDICAL FLIGHT CREW THROUGH THE TEMPORARY AND PERMANENT RESOLUTION VIA FACETIME. DURING IMPELLA CP SUPPORT, THERE WAS AN ISSUE WITH THE DEVICE IN THE WRONG POSITION AND REPOSITIONING IT. IT WAS STATED THAT THE IMPELLA WAS TOO SHALLOW AND REPOSITIONED AT BESIDE, BUT THE IMPELLA CP WAS FACING THE LATERAL WALL WHICH MADE IT DIFFICULT TO ADVANCE. THE CARE TEAM DECIDED TO STOP TRYING THE ADVANCE BECAUSE THERE WERE NO IMPELLA CONCERNS AND URINE OUTPUT WAS CLEAR. THE IMPELLA CP DEPTH WAS ABOUT 2 CM IN THE LEFT VENTRICLE. LATER THAT DAY, THE PATIENT WAS REPORTED TO BE VERY UNCOMFORTABLE AND WAS TAKEN TO THE CATH LAB FOR AN IMPELLA REPOSITIONING AND SWAN INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662463 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026728766 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention