BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RP FLEX

    MDR report key: 23975119 · Received January 6, 2026

    Report

    Report Number
    1220648-2025-49686
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 11, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY/CLINICAL REVIEWED THE EVENT. THIS EVENT INVOLVES A PATIENT DIAGNOSED WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS) AND LOW CARDIAC OUTPUT SYNDROME (LCOS), STAGE D, WHO UNDERWENT IMPLANTATION OF AN IMPELLA 5.5 DEVICE. FOLLOWING DIRECT PLACEMENT OF THE IMPELLA 5.5, THE PATIENT EXPERIENCED EPISODES OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION (VT/VF) AND REQUIRED MULTIPLE DEFIBRILLATION SHOCKS TO ACHIEVE NORMAL SINUS RHYTHM. AN ECHOCARDIOGRAPHIC ASSESSMENT WAS PERFORMED AND DOCUMENTED APPROPRIATE IMPELLA 5.5 POSITIONING; NO DEVICE REPOSITIONING WAS REQUIRED. SUBSEQUENT ATTEMPTS WERE MADE TO PROVIDE BIVENTRICULAR MECHANICAL CIRCULATORY SUPPORT USING AN IMPELLA RP FLEX DEVICE. THE ATTEMPTS WERE UNSUCCESSFUL DUE TO THE INABILITY TO ADVANCE THE DEVICE INTO THE PULMONARY ARTERY. THE RP FLEX PROCEDURE WAS ABORTED, AND NO PROCEDURAL COMPLICATIONS WERE REPORTED BASED ON THE INFORMATION AVAILABLE. APPROXIMATELY 24 HOURS LATER, A DECISION WAS MADE TO WITHDRAW LIFE-SUSTAINING CARE, AND THE PATIENT SUBSEQUENTLY EXPIRED. NOTE: H6. INVESTIGATION TYPE/FINDINGS/CONCLUSION REMAINS UNCHANGED. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO PRODUCT RETURNED. UNABLE TO DELIVER OR ADVANCE: THE CAUSE OF THE DELIVER ISSUE WAS DETERMINED TO BE PATINET CONDITION AS THE PATIENT HAD DIFFICULT ANATOMY AND RESISTANCE AT PULMONIC VALVE PREVENTING SUCCESSFUL DELIVERY OF IMPELLA. DEVICE HISTORY LOT: DEVICE LOT: 1931619. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE SN 600768 PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    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 THAT A PATIENT WAS BEING IMPLANTED WITH AN IMPELLA RP FLEX VIA THE RIGHT FEMORAL VEIN FOR MECHANICAL CIRCULATORY SUPPORT. MULTIPLE ATTEMPTS WERE MADE TO IMPLANT THE IMPELLA RP, HOWEVER THE PHYSICIAN WAS NOT SUCCESSFUL AT ADVANCING THE DEVICE PASSED THE PULMONARY ARTERY. THE DECISION WAS MADE TO ABORT THE IMPELLA RP FLEX IMPLANT. ADDITIONALLY, THE PATIENT WAS INITIALLY SUPPORTED BY AN IMPELLA 5.5 WHICH WAS SUCCESSFULLY INSERTED VIA THE AORTA THE SAME DAY IMPELLA RP FLEX ATTEMPTED TO BE IMPLANTED. DURING THE FIRST DAY OF IMPELLA 5.5 SUPPORT, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION AND REQUIRED DEFIBRILLATION TO OBTAIN NORMAL SINUS RHYTHM. SUBSEQUENTLY, THE PATIENT EXPIRED AFTER SUPPORT WAS WITHDRAWN THE FOLLOWING DAY. ADDITIONAL CLINICAL DETAILS, INCLUDING PERIOPERATIVE COURSE, CONTRIBUTING FACTORS, AND CAUSE OF DEATH, WERE UNAVAILABLE AT THE TIME OF REPORTING. THIS COMPLAINT INVOLVES TWO IMPELLA DEVICES: PUMP 1: IMPELLA 5.5 WITH SERIAL NUMBER (B)(6), PUMP 2: IMPELLA RP FLEX, WITH SERIAL NUMBER (B)(6). THIS MDR SPECIFICALLY ADDRESSES PUMP 2: IMPELLA RP FLEX, WITH SERIAL NUMBER (B)(6), WHICH IS THE SUBJECT OF THIS REPORT. SEPARATE MDRS WILL BE SUBMITTED FOR THE OTHER DEVICES ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515912 IMPELLA RP FLEX TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP FLEX 2026709767 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male