BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 23500867 · Received November 7, 2025

    Report

    Report Number
    1220648-2025-48195
    Event Type
    Death
    Date Received
    November 7, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 7, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    D1 BRAND NAME WAS UPDATED. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION. MINOR BLEED: HAVING BLEEDING FROM AIRWAY AFTER ET TUBE EXCHANGE YESTERDAY WITH LARGE SEGMENTAL CLOTS FORMING IN BRONCHIOLES S/P TRANSEMIC ACID. HAD TO PAUSE HEPARIN D/T BLEEDING. GOAL TO EXPLANT RP FLEX TODAY & PAUSE HEPARIN IN ORDER TO STOP AIRWAY BLEEDING IN ORDER TO EXTUBATE. THE CAUSE OF THE BLEEDING IS DETERMINED TO BE PATIENT CONDITION BECAUSE THE BLEEDING SOURCE IS AT NON IMPELLA SITE. RENAL FAILURE: THE CAUSE OF THE INJURY IS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D4 (CATALOG). 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

    MEDICAL SAFETY/CLINICAL REVIEWED THE EVENT. A 79-YEAR-OLD PATIENT WITH A SIGNIFICANT PAST MEDICAL HISTORY INCLUDING HEART FAILURE WITH REDUCED EJECTION FRACTION, CORONARY ARTERY DISEASE WITH PRIOR CABG (2010), PAROXYSMAL ATRIAL FIBRILLATION, AND AORTIC STENOSIS STATUS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS TRANSFERRED FROM AN OUTSIDE FACILITY AFTER SEVERAL DAYS OF NOT FEELING WELL. TROPONIN WAS ELEVATED TO 1600, AND THE PATIENT MET SHOCK ALERT CRITERIA WITH HEMODYNAMIC COMPROMISE (CPO 0.3, PAPI 0.3). THE PATIENT UNDERWENT LEFT HEART CATHETERIZATION, WHICH REVEALED LESIONS IN THE LEFT CIRCUMFLEX ARTERY AND SAPHENOUS VEIN GRAFT TO POSTERIOR DESCENDING ARTERY. GIVEN REFRACTORY CARDIOGENIC SHOCK, THE DECISION WAS MADE TO INITIATE BIVENTRICULAR MECHANICAL CIRCULATORY SUPPORT WITH PLACEMENT OF AN IMPELLA RP FLEX AND CONSULTATION WITH CARDIOTHORACIC SURGERY FOR AXILLARY PLACEMENT OF AN IMPELLA CP WHICH WAS SUCCESSFULLY PLACED. THE FOLLOWING DAY, THE PATIENT UNDERWENT CARDIOVERSION FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. ADDITIONALLY NOTED, PATIENT WAS ANURIA AND CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS INITIATED. THE PATIENT REMAINED ON BIPELLA SUPPORT WITH INTERMITTENT DEPENDENCE ON BOTH MECHANICAL AND PHARMACOLOGIC CIRCULATORY SUPPORT. APPROXIMATELY THREE DAYS LATER, IT WAS NOTED AIRWAY BLEEDING FOLLOWING AN ENDOTRACHEAL TUBE EXCHANGE PERFORMED, THE PRIOR DAY, WITH FORMATION OF LARGE SEGMENTAL CLOTS WITHIN THE BRONCHIOLES. THE PATIENT WAS TREATED WITH TRANEXAMIC ACID. SYSTEMIC HEPARIN WAS PAUSED DUE TO BLEEDING, WITH PLANS TO RESUME WHEN CLINICALLY SAFE. THE CARE PLAN INCLUDED WEANING VASOACTIVE INFUSIONS AS TOLERATED AND EVENTUAL EXPLANT OF THE IMPELLA RP FLEX, WITH INTERRUPTION OF ANTICOAGULATION TO OBTAIN HEMOSTASIS AND PLANNED EXTUBATION. SUBSEQUENT INFORMATION CLARIFIED THAT ATRIAL FIBRILLATION WAS PRESENT AT THE TIME OF IMPELLA IMPLANTATION AND HAD BEEN ONGOING FOR GREATER THAN THREE DAYS PER PACEMAKER INTERROGATION; CARDIOVERSION WAS INTENTIONALLY DEFERRED UNTIL MECHANICAL SUPPORT WAS ESTABLISHED. THE AIRWAY BLEEDING WAS DETERMINED TO BE SECONDARY TO TRAUMATIC INJURY FROM THE ENDOTRACHEAL TUBE EXCHANGE, CONFIRMED BY BRONCHOSCOPY. DESPITE THE PAUSE OF HEPARIN, THE BLEEDING COULD NOT BE CONTROLLED, AND THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE DUE TO ACUTE BLOOD LOSS. AFTER DISCUSSION WITH THE FAMILY, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. ALTHOUGH THE AIRWAY BLEEDING WAS ATTRIBUTED TO PROCEDURAL TRAUMA AND NOT DEVICE MALFUNCTION, THE REQUIREMENT FOR SYSTEMIC ANTICOAGULATION DURING IMPELLA SUPPORT MAY HAVE CONTRIBUTED TO THE SEVERITY OF BLEEDING. BOTH THE IMPELLA RP FLEX AND THE IMPELLA CP ARE BEING REPORTED AS DEATH-TYPE REPORTABLE EVENT; EACH DEVICE WAS IN USE PRECEDING THE PATIENT'S DEMISE. CORRECTION. COMPLAINT CODING WAS UPDATED TO BETTER DESCRIBE THE REPORTED EVENT. THEREFORE H6. HEALTH EFFECT - CLINICAL AND IMPACT CODING WAS UPDATED/CORRECTED AND REPOPULATED. B7. MEDICAL HISTORY AND D10. CONCOMITANT PRODUCT WERE ALSO UPDATED ACCORDINGLY. 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

    CORRECTION: E4. THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. MINOR BLEED: THE CAUSE OF THE BLEEDING IS DETERMINED TO BE PATIENT CONDITION BECAUSE THE BLEEDING SOURCE IS AT NON-IMPELLA SITE. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED PATIENT HAD A BIPELLA PLACED FOR SUPPORT OF RP FLEX AND CP FOR THE PATIENT ADMITTED IN WITH EXTENSIVE CARDIAC HISTORY AND SURGERIES AND NOW IN SHOCK. THE RP WAS PLACED BUT ON 2ND DAY OF SUPPORT THE ATRIAL FIBRILLATION THAT WAS PRESENT AND PRE-EXISTING PROMPTED CARDIOVERSION AND DAYS LATER WITH BLEEDING AFTER ENDOTRACHEAL TUBE EXCHANGE THE HEPARIN WAS STOPPED. THE NEXT DAY THE PUMP SUPPORTS WERE WITHDRAWN AND PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186732 IMPELLA TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. RP FLEX 2025488365 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death| R