BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24606182 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05325
    Event Type
    Death
    Date Received
    March 16, 2026
    Date of Event
    February 26, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS RETURNED FOR EVALUATION. NO ISSUES RELATED TO THE REPORTED PRIMING PROBLEM WERE IDENTIFIED WITHIN THE AIC OR THE PURGE ASSEMBLY. D4 UDI REVISED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED D9 WAS UPDATED. THE INVESTIGATION IS UNDERWAY ONCE COMPLETED A SUPPLEMENTAL WILL BE SENT.

    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. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Additional Manufacturer Narrative · 0

    CORRECTIONS WERE MADE TO THE FOLLOWING SECTIONS THAT WERE ERRONEOUSLY REPRESENTED ON THE INITIAL REPORT: 1. H5 ¿ LABELED FOR SINGLE USE: CORRECTED TO NO (FROM YES). 2. H8 ¿ USAGE OF DEVICE: CORRECTED TO REUSE (FROM INITIAL USE).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND NOTED THE OUTCOME AT THE END OF UNIT SUPPORT WAS CARE WAS WITHDRAWN AND PATIENT SUBSEQUENTLY EXPIRED. THE CLINICAL ASSESSMENT WAS UPDATED, AND THE CHANGES ARE REFLECTED IN SECTION B5 (EVENT DESCRIPTION), INCLUDING A REVISION TO THE REPORTABILITY ASSESSMENT. FOLLOWING THE CLINICAL ASSESSMENT, THE TYPE OF REPORTABLE EVENT WAS CHANGED TO DEATH. AS A RESULT, SECTION B1 (ADVERSE EVENT/PRODUCT PROBLEM), B2 (OUTCOMES ATTRIBUTED...), H1 (TYPE OF REPORTABLE EVENT) AND H6 (HEALTH EFFECT-CLINICAL, HEALTH EFFECT-IMPACT AND MEDICAL DEVICE PROBLEM) CODING HAVE BEEN FULLY UPDATED AND SHOULD BE CONSIDERED THE ACCURATE REPRESENTATION OF THE EVENT. NOTE: THE ACTUAL DATE OF DEATH IS NOT KNOWN AT THE TIME OF THIS FOLLOW-UP REPORT. A PROVISIONAL DATE, BASED ON THE EXPLANT DATE, HAS BEEN RECORDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF THE CONFIRMED DATE OF DEATH OR ANY NEW, RELEVANT INFORMATION. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10. CORRECTION. SECTION D1 BRAND NAME WAS CORRECTED ACCORDINGLY.

    Description of Event or Problem · 0

    A 58-YEAR-OLD FEMALE WITH CARDIOMYOPATHY AND A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D UNDERWENT IMPLANTATION OF AN IMPELLA 5.5 (SN (B)(6)) ON (B)(6) 2026 AT 9:17 AM VIA RIGHT AXILLARY/SUBCLAVIAN SURGICAL ARTERIAL ACCESS. DURING DEVICE PREPARATION, AFTER STARTING THE AIC, THE PERFUSIONIST FOLLOWED STANDARD PROMPTS AND SPIKED THE PURGE SOLUTION. ALTHOUGH THE PURGE CASSETTE WAS INSERTED CORRECTLY, THE CASSETTE REPEATEDLY FAILED TO INITIATE PURGE. TROUBLESHOOTING INCLUDED RESEATING THE PURGE CASSETTE, RESTARTING SETUP, SWITCHING AICS, AND ULTIMATELY REPLACING THE PURGE CASSETTE. THE SECOND PURGE CASSETTE PURGED NORMALLY WITHOUT FURTHER ISSUES. SUBSEQUENTLY, THE BEDSIDE RN REPORTED THAT THE AIC UNEXPECTEDLY SHUT DOWN AND REBOOTED, GENERATING A WHITE ADVISORY ALARM STATING ¿UNEXPECTED CONTROLLER SHUT DOWN¿ WITH DIRECTIONS TO SWITCH TO THE BACKUP CONTROLLER IF THE CONDITION PERSISTED. THE MEDICAL TEAM ELECTED TO POSTPONE SWITCHING CONTROLLERS AND INSTEAD MAINTAIN THE BACKUP UNIT AT BEDSIDE. THE PATIENT REMAINED ON SUPPORT, AND NO DEVICE REMOVAL OCCURRED DUE TO THE MALFUNCTION. THE REPORTED EVENTS INVOLVED A PURGE CASSETTE PRIMING FAILURE FOLLOWED BY AN UNEXPECTED AIC SHUTDOWN AND REBOOT. REPLACEMENT OF THE PURGE CASSETTE RESOLVED THE PURGE ISSUE, AND NO FURTHER DEVICE RELATED COMPLICATIONS WERE OBSERVED. THE DEVICE REMAINED IN USE, THE PATIENT REMAINED SUPPORTED, AT THE TIME OF REPORTING.

    Description of Event or Problem · 0

    A 58-YEAR-OLD FEMALE WITH CARDIOMYOPATHY AND A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D UNDERWENT IMPLANTATION OF AN IMPELLA 5.5 (SN (B)(6)) ON (B)(6) 2026 AT 9:17 AM VIA RIGHT AXILLARY/SUBCLAVIAN SURGICAL ARTERIAL ACCESS. DURING DEVICE PREPARATION, AFTER STARTING THE AUTOMATED IMPELLA CONTROLLER (AIC), THE PERFUSIONIST FOLLOWED STANDARD PROMPTS AND SPIKED THE PURGE SOLUTION. ALTHOUGH THE PURGE CASSETTE WAS INSERTED CORRECTLY, THE CASSETTE REPEATEDLY FAILED TO INITIATE PURGE. TROUBLESHOOTING INCLUDED RESEATING THE PURGE CASSETTE, RESTARTING SETUP, SWITCHING AICS, AND ULTIMATELY REPLACING THE PURGE CASSETTE. THE SECOND PURGE CASSETTE PURGED NORMALLY WITHOUT FURTHER ISSUES. SUBSEQUENTLY, THE BEDSIDE RN REPORTED THAT THE AIC UNEXPECTEDLY SHUT DOWN AND REBOOTED, GENERATING A WHITE ADVISORY ALARM STATING ¿UNEXPECTED CONTROLLER SHUT DOWN¿ WITH DIRECTIONS TO SWITCH TO THE BACKUP CONTROLLER IF THE CONDITION PERSISTED. THE MEDICAL TEAM ELECTED TO POSTPONE SWITCHING CONTROLLERS AND INSTEAD MAINTAIN THE BACKUP UNIT AT BEDSIDE. THE REPORTED EVENTS INVOLVED A PURGE CASSETTE PRIMING FAILURE FOLLOWED BY AN UNEXPECTED AIC SHUTDOWN AND REBOOT. REPLACEMENT OF THE PURGE CASSETTE RESOLVED THE PURGE ISSUE, AND NO FURTHER DEVICE RELATED COMPLICATIONS WERE OBSERVED. THE DEVICE REMAINED IN USE, THE PATIENT REMAINED SUPPORTED, AT THE TIME OF REPORTING. ADDITIONAL INFORMATION PROVIDED ON 3/16/2026 THE CARE WAS WITHDRAWN AND DEVICE EXPLANT AND PATIENT SUBSEQUENTLY EXPIRED. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA AIC BUT IS UNLIKELY A CONTRIBUTING FACTOR AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS (SCAI) STAGE D SHOCK ON MULTIPLE INOTROPES AND PRESSORS AND WAS VENTILATED FOR RESPIRATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255118 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 1751872 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1