BEUDAMED
    FDA Adverse Event Death Summary report: N

    PC GEN 2, NON-QSK, STERILE, JAPAN

    MDR report key: 24430807 · Received February 24, 2026

    Report

    Report Number
    1220648-2026-03916
    Event Type
    Death
    Date Received
    February 24, 2026
    Date of Event
    January 23, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3 (MANUFACTURER FAX) AND G1 (MANUFACTURER CONTACT FAX NUMBER) HAS BEEN OMITTED FROM INITIAL MEDWATCH. 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

    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

    THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PURGE PRESSURE LOW: THE CAUSE OF THE PURGE PRESSURE LOW WAS NOT DETERMINED DUE TO NO PRODUCT RETURNED AND INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICIAN NARRATIVE UPDATED: AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 72-YEAR-OLD MALE WHO WAS TRANSPORTED FOR EMERGENT OPEN-HEART SURGERY DUE TO CARDIAC RUPTURE FOLLOWING MYOCARDIAL INFARCTION. THE RUPTURE WAS LOCATED IN THE LAD REGION AND WAS DESCRIBED AS A BLOWOUT TYPE. THE DEVICE WAS PLACED FOR PRE-OPERATIVE SUPPORT IN THE SETTING OF CARDIOGENIC SHOCK, SCAI STAGE C, WHILE THE PATIENT WAS ON ECMO. THE PURGE SOLUTION CONSISTED OF D5W. NO ADDITIONAL PAST MEDICAL HISTORY WAS PROVIDED. PRIOR TO PUMP INTRODUCTION, IT WAS REPORTED THAT THE POWER WAS TURNED ON BEFORE THE IMPELLA CATHETER WAS INSERTED, AND THE CONTROL UNIT WAS REPLACED DUE TO AN INITIAL DIAGNOSTIC ERROR. THIS WAS ADDRESSED PRIOR TO USE IN THE PATIENT AND DID NOT RESULT IN REPORTED CLINICAL CONSEQUENCES. DURING SUPPORT, THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY, AND THE OPTICAL/AIC COMPONENT WAS REVISED OR REPLACED AS PART OF ONGOING MANAGEMENT WHILE THE PATIENT REMAINED CRITICALLY ILL ON ECMO. REGARDING THE GUIDEWIRE, THE TIP WAS FOUND TO BE KINKED DURING IMPELLA INSERTION UPON OPENING THE PACKAGE AND REMOVING THE FLOPPY TIP. THE ISSUE WAS RESOLVED BY EXCHANGING THE WIRE. NO SIGNS, SYMPTOMS, OR PATIENT CONSEQUENCES WERE REPORTED IN ASSOCIATION WITH THE KINKED WIRE. A PURGE PRESSURE LOW ALARM WAS REPORTED IN ASSOCIATION WITH THE PURGE CASSETTE AND HOUSING DURING SUPPORT. THE PURGE HOUSING WAS REPLACED, AND THE ISSUE WAS REPORTED AS RESOLVED. OTHER THAN THE ALARM, NO ADDITIONAL ISSUES DURING SUPPORT WERE DESCRIBED, AND THERE WERE NO VISIBLE CASSETTE LEAKS OR DAMAGE REPORTED. PATIENT CONTINUED TO DETERIORATE AND ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF DEATH WAS MULTIPLE ORGAN FAILURE FOLLOWING SURGERY. THE PROVIDER STATED THAT THERE WAS NO RELATIONSHIP BETWEEN THE IMPELLA DEVICE AND THE PATIENT¿S DEATH AND COMMENTED THAT THE DEVICE OPERATED PROPERLY THROUGHOUT SUPPORT. THE DEATH IS BEING CONSERVATIVELY REPORTED IN ASSOCIATION WITH THE EVENT; HOWEVER, IT IS MORE LIKELY ATTRIBUTABLE TO THE PATIENT¿S CARDIAC RUPTURE SECONDARY TO MYOCARDIAL INFARCTION, HIGH-RISK SURGICAL COURSE, AND SUBSEQUENT MULTIPLE ORGAN FAILURE. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112943 PC GEN 2, NON-QSK, STERILE, JAPAN TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death