BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP FLEX

    MDR report key: 21044414 · Received December 30, 2024

    Report

    Report Number
    1220648-2024-25157
    Event Type
    Death
    Date Received
    December 30, 2024
    Date of Event
    December 9, 2024
    Report Date
    September 30, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO DAYS LATER IN THE MORNING, IT WAS NOTED THE PERCLOSE AT THE INITIALLY IMPLANTED IMPELLA CP SITE (LEFT SUBCLAVIAN ARTERY) POPPED DURING THE PATIENT'S COUGHING FIT. MANUAL PRESSURE WAS HELD FOR ONE HOUR, PACKED RED BLOOD CELLS AND PLATELETS WERE GIVEN. THE PATIENT WAS TAKEN TO THE CARDIOVASCULAR OPERATING ROOM FOR REPAIR. PLASMA FREE HEMOGLOBIN WAS DOWN TO 60. THE PATIENT WENT BACK TO THE OPERATING ROOM THAT AFTERNOON FOR AN ANGIOGRAM OF THE LEFT SUBCLAVIAN ARTERY AND BLEEDING WAS NOTED. A COVERED STENT WAS DEPLOYED. FURTHER NOTED, THE IMPELLA 5.5 WAS POINTING TOWARDS THE MITRAL ON TEE, THE IMPELLA 5.5 WAS SUCCESSFULLY REPOSITIONED AND NOW POINTING TOWARD APEX. BILATERALLY CHEST TUBES, RIGHT SIDE FOR PLEURAL EFFUSION AND LEFT SIDE FOR HEMOTHORAX. HEMOGLOBIN WAS 7 G/DL WITH CONTINUOUS BLEEDING FROM CHEST TUBES, AND A PLAN TO GIVE MULTIPLE BLOOD PRODUCTS. THERE WERE SUCTION EVENTS ON BIPELLA PUMPS NOTED LIKELY FROM VOLUME LOSS, AND ALBUMIN AND PRODUCTS WERE INFUSED. NEXT STEP PLAN: FIX FLUID STATUS, MONITOR CHEST TUBE OUTPUT, AND [RE]START CONTINUOUS RENAL REPLACEMENT THERAPY WITH A POSSIBLE RETURN TO CATHETERIZATION LAB LATER THE SAME DAY OR THE FOLLOWING DAY TO EVALUATE CORONARIES. HOWEVER, THE PATIENT WOULD EXPIRE THE FOLLOWING DAY. THE PATIENT HAD AN EJECTION FRACTION OF JUST 10-15% AND WAS VERY UNWELL GOING INTO THE PROCEDURE FOR THE IMPELLA. THE CAUSE OF DEATH IS UNKNOWN. THERE WERE IMPELLA-RELATED EVENTS THAT OCCURRED DURING IMPELLA MCS AND THERE IS NOT, HOWEVER, ENOUGH INFORMATION TO EXCLUDE IMPELLA RP FLEX AS AN ASSOCIATED FACTOR IN THE PATIENT¿S OUTCOME. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. THIS IS ONE OF THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THE EVENT(S). REFER TO MANUFACTURING REPORT NUMBERS 11220648-2024-25113 (FOR IMPELLA CP) AND 1220648-2024-25097 (IMPELLA 5.5).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE LOW PUMP FLOW HAS BEEN COMPLETED. THE PUMP WAS NOT RETURNED FOR INVESTIGATION, AND THE DATA LOG WAS NOT PROVIDED FOR THIS CASE. ACCORDING TO THE CLINICAL NOTES, THE PLACEMENT SIGNAL WAS LOST ON THE SECOND DAY, AND SUCTION ALARMS WERE REPORTED ON BOTH DEVICES, LIKELY DUE TO BLOOD LOSS ON THE THIRD DAY. THE CAUSE OF THE LOW PUMP FLOW ISSUE WAS NOT DETERMINED SINCE THE PRODUCT WAS NOT RETURNED AND DATA LOG WAS NOT PROVIDED FOR THIS CASE. B.7 HYPERLIPIDEMIA WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-25157. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-25157 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. G.1 REVISED MANUFACTURING SITE NAME AND ADDRESS AS THEY WERE PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-25157.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES, PER FDA RECOMMENDATION. THE INVESTIGATION HAS BEEN COMPLETED. THE CAUSE OF THE OPTICAL ISSUE WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED AND SUFFICIENT CLINICAL INFORMATION WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUSPECT PRODUCT AND HISTORICAL COMPLAINT DATA WAS CONDUCTED. THIS REVIEW REVEALED THAT THE PRODUCT MET ALL MANUFACTURING RELEASE CRITERIA, AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED AT THE TIME THE PRODUCT WAS MANUFACTURED AND RELEASED TO THE CUSTOMER. ALL PERTINENT INFORMATION AVAILABLE TO ABIOMED HAS BEEN SUBMITTED AT THIS TIME. B5 UPDATED TO INCLUDE PLACEMENT SIGNAL DESCRIPTION. H6 UPDATED TO INCLUDE PLACEMENT SIGNAL CODING.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT WITH CARDIOGENIC SHOCK FROM AN ACUTE MYOCARDIAL INFARCTION WITH AN EJECTION FRACTION OF 10-15% WAS INITIALLY IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT (MCS) AND APPROXIMATELY TWO DAYS LATER, WAS ESCALATED TO AN IMPELLA 5.5 AND ADDED THE IMPELLA RP FLEX SUPPORT FOR THE RIGHT VENTRICLE. HOWEVER, THE PATIENT WOULD EVENTUALLY EXPIRE. CARDIOTHORACIC SURGERY TURNED DOWN THE PATIENT FOR CORONARY ARTERY BYPASS GRAFT SURGERY AND RECOMMENDED HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI). AHF ALSO CONSULTED AND RECOMMENDED ESCALATION TO IMPELLA 5.5 FROM THE IMPELLA CP (TWO DAYS AFTER START OF THIS SUPPORT) IN WHICH HEMOLYSIS WAS EXPERIENCED. THE PHYSICIAN MADE THE DECISION TO TAKE THE PATIENT TO CATHETERIZATION LAB FOR HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) AND EVALUATED NEED FOR ESCALATION AFTER REVASCULARIZING. DURING THE HRPCI, THE PATIENT DECOMPENSATED, HAD VENTRICULAR FIBRILLATION ARREST, AND REQUIRED VASOPRESSOR SUPPORT. THE CARDIOTHORACIC SURGEON WAS CALLED, ARRIVED AT THE CATHETERIZATION LAB, AND DECIDED TO IMPLANT IMPELLA 5.5 IN THE LAB. VENOUS BLEEDING WAS NOTED IN IMPELLA 5.5 SITE AXILLARY CUTDOWN. SURGICEL UTILIZED, PACKING, AND BLOOD TRANSFUSED AND OOZING RESOLVED. THE PATIENT HAD DECREASED FLOWS ON IMPELLA 5.5, PERSISTENT SUCTION EVENTS, AND THE RIGHT VENTRICLE WAS DILATED ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT CONTINUED TO DECOMPENSATE AND HAD ANOTHER VENTRICULAR FIBRILLATION ARREST WHILE CLOSING IMPELLA 5.5 SITE. DECISION MADE TO EMERGENTLY PLACE IMPELLA RP FLEX. THE PATIENT WAS TRANSFERRED TO THE UNIT ON BIPELLA (IMPELLA 5.5 AND RP FLEX) SUPPORT...CONTINUES IN H10.

    Description of Event or Problem · 0

    THE COMPLAINANT ALSO REPORTED THAT THERE WERE PLACEMENT SIGNAL NOT RELIABLE ALARMS. AUDIO WAS DISABLED AND SUPPORT CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226597 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2025560902 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| D IMPELLA 5.5.