BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25145710 · Received May 12, 2026

    Report

    Report Number
    1220648-2026-07738
    Event Type
    Death
    Date Received
    May 12, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 10, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN D3( MANUFACTURER FAX); D10(CONCOMITANT MED PRODUCTS); UPON REVIEW, IT WAS IDENTIFIED THAT THE INFORMATION WAS INADVERTENTLY NOT SUBMITTED IN THE INITIAL REPORT. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 68-YEAR-OLD FEMALE PATIENT FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), PRESENTING IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E SHOCK. EARLIER IN THE COURSE, THE LARGE-BORE SHEATH HAD BEEN PEELED AWAY, WITH A REPOSITIONING SHEATH REMAINING IN PLACE. THE PATIENT WAS WEANED TO IMPELLA CP EXPLANT. FOLLOWING DEVICE REMOVAL, AN ANGIOGRAM WAS PERFORMED, WHICH DEMONSTRATED COMPLETE OCCLUSION OF THE DISTAL AORTA EXTENDING INTO BOTH FEMORAL ARTERIES. PRIOR TO THIS FINDING, THE PATIENT HAD REPERFUSION SHEATHS IN PLACE BILATERALLY, ON BOTH THE IMPELLA AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) ACCESS SIDES. DISTAL PULSES WERE PRESENT BILATERALLY THROUGHOUT THE PATIENT¿S INTENSIVE CARE UNIT COURSE. SYSTEMIC HEPARIN ANTICOAGULATION HAD BEEN HELD FOR MULTIPLE DAYS DUE TO BLEEDING AT THE ECMO ACCESS SITE. THE ETIOLOGY OF THE VASCULAR OCCLUSION WAS UNCERTAIN, WITH CONSIDERATIONS INCLUDING VASCULAR DISSECTION VERSUS THROMBUS FORMATION. VASCULAR SURGERY WAS CONSULTED AND DETERMINED THAT NO FURTHER INTERVENTION WAS FEASIBLE. THE PATIENT SURVIVED TO IMPELLA EXPLANT. THE PATIENT SUBSEQUENTLY EXPIRED AT A LATER TIME FOLLOWING DEVICE REMOVAL. THE DEATH IS BEING REPORTED; HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE DEATH IS UNLIKELY RELATED TO IMPELLA DEVICE PERFORMANCE AND IS MORE LIKELY ATTRIBUTABLE TO THE PATIENT¿S UNDERLYING CLINICAL CONDITION AND DISEASE SEVERITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66061 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027849362 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1