BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 22952189 · Received September 3, 2025

    Report

    Report Number
    1220648-2025-46098
    Event Type
    Death
    Date Received
    September 3, 2025
    Date of Event
    August 5, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED. OPTICAL SENSOR ISSUE: CLINICAL DETAILS NOTE THAT THE AO CONSISTENTLY READ 20 MMHG LOWER THAN THE ARTERIAL LINE AFTER THE DEVICE STARTED. AO SIGNAL WAS RECALIBRATED. DATA LOG REVIEW SHOWED PS AT ~50 MMHG AFTER PUMP STARTUP. SHORTLY AFTER, A 22 MMHG ADJUSTMENT WAS MADE TO THE PS. THERE WERE NO ABNORMALITIES WITH THE OPTICAL PARAMETERS DURING THE CASE. BASED ON IMC LOGS, THERE WERE NO ABNORMALITIES WITH OPTICAL SENSOR CALIBRATION (FACTORY G0=15764 AND CALIBRATED G0=15750). THE CAUSE OF THE OPTICAL SENSOR ISSUE WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. MAJOR BLEED: CLINICAL DETAILS NOTE THAT THERE WAS AN ACTIVE GI BLEED ON 08-AUG-2025. HEPARIN HAD BEEN ADMINISTERED DURING PUMP IMPLANT. DATA LOGS ARE NOT APPLICABLE. THE CAUSE OF THE CLINICAL SYMPTOM CANNOT BE DETERMINED AS INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. DEVICE HISTORY LOT : DEVICE LOT: 1942024. DEVICE HISTORY BATCH : SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW : THE PUMP SN (B)(6) PASSED ALL POST-STERILE INSPECTION CHECKS. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION/ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. EVENT LOGS WERE RECEIVED AND ANALYZED. THE INVESTIGATION WAS COMPLETED AND NOTED A DEVICE HISTORY RECORD REVIEW CONFIRMED THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA 5.5 CANNOT BE DISSOCIATED FROM THE PATIENT'S OUTCOME. IT CANNOT BE DETERMINED IF THE USE OF HEPARIN FOR IMPLANT OF THE IMPELLA 5.5 DEVICE IMPACTED/EXACERBATED THE OUTCOME OF THE BLEED FOR THE PATIENT. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT (MCS) EXPERIENCED GASTROINTESTINAL BLEEDING REQUIRING INTERVENTION AND WOULD SUBSEQUENTLY EXPIRE. THE PATIENT WAS ADMITTED FOR HEART FAILURE EXACERBATION AND WORK UP FOR ADVANCED THERAPIES. THE PATIENT WENT INTO CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION AND RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED. THE PATIENT WAS UPGRADED TO THE CRITICAL CARE UNIT IN CARDIOGENIC SHOCK AND TRANSPORTED TO THE OPERATING ROOM FOR INNOMINATE VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) AND IMPELLA 5.5 PLACEMENT AS A BRIDGE TO ADVANCED THERAPIES. THE INNOMINATE ARTERY WAS CUT DOWN. A 10 MILLIMETER GRAFT WAS ATTACHED AND TUNNELED WITH A PLAN TO CUT AND SEW THE BIFURCATING SIDE ARM TO BE USED FOR ARTERIAL CANNULA AND IMPELLA 5.5. HEPARIN WAS GIVEN. ACTIVATED CLOTTING TIME WAS 326. OOZING AT GRAFT SITE AND HYPOTENSION WERE NOTED. THE BLEEDING WAS CONTROLLED SURGICALLY. CELLSAVER PRODUCT WAS GIVEN. THE DECISION WAS MADE TO CANNULATE VA ECMO FIRST DUE TO THE PATIENT¿S HEMODYNAMIC INSTABILITY AND IMPELLA 5.5 TO FOLLOW, WHICH WERE COMPLETED AS DECIDED. THE PATIENT WAS SENT TO THE UNIT ON SUPPORT. TWO DAYS LATER, IN THE MORNING, LACTATE DEHYDROGENASE TRENDED UP. AN ECHOCARDIOGRAM WAS COMPLETED. THE IMPELLA 5.5 APPEARED TO BE IN STABLE POSITION. LATER THAT AFTERNOON, THE PATIENT WAS ACUTELY DECOMPENSATING WITH METABOLIC ACIDOSIS AND LACTATE 11. ACTIVE GASTROINTESTINAL BLEED WAS NOTED. THE PATIENT WAS REINTUBATED WITH INCREASED PRESSORS AND INOTROPES AND PLANNED FOR EXPLORATORY LAPAROSCOPY. DIFFUSE BOWEL NECROSIS WAS NOTED, AND THE PATIENT WAS SUBSEQUENTLY NO LONGER A CANDIDATE FOR ADVANCE THERAPIES. THE FAMILY MADE THE DECISION TO WITHDRAW CARE AND THEREAFTER THE PATIENT EXPIRED. ADDITIONALLY, OF NOTE, THE AORTIC SENSOR READ CONSISTENTLY 20 MMHG LOWER THAN ARTERIAL LINE AFTER THE DEVICE WAS STARTED. A DISCUSSION WITH THE SURGEON WAS HAD AND THE SURGEON OPTED TO RECALIBRATE THE AORTIC SIGNAL. NO ABNORMALITIES NOTED TO AORTIC SENSOR TRACING DURING PUMP PRIME AND NO EXCESSIVE FORCE WAS APPLIED DURING PREP AND INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473275 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026707503 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Death| R VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION