BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25080134 · Received May 5, 2026

    Report

    Report Number
    1220648-2026-07464
    Event Type
    Death
    Date Received
    May 5, 2026
    Date of Event
    April 28, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE DELIVERY/REMOVAL ISSUE WAS PATIENT CONDITION RELATED TO CALCIFICATION.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN 85-YEAR-OLD FEMALE WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, WITH A PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE B, UNDERWENT IMPELLA CP SUPPORT VIA LEFT FEMORAL ARTERIAL ACCESS ON (B)(6) 2026 AT 14:50. THE PATIENT HAD KNOWN SEVERE PERIPHERAL ARTERIAL DISEASE WITH EXTENSIVE GLOBAL VASCULAR CALCIFICATIONS. DURING ATTEMPTED DEVICE PLACEMENT, SEVERE CALCIFICATION AT THE DISTAL DESCENDING AORTA NEAR THE BIFURCATION PREVENTED ADVANCEMENT OF THE IMPELLA CP DESPITE SERIAL PRE-DILATION. VASCULAR SURGERY WAS CONSULTED, AND A SINGLE ARTERIAL ACCESS APPROACH WAS USED TO BALLOON THE TERMINAL AORTA, AFTER WHICH THE IMPELLA CP WAS SUCCESSFULLY ADVANCED. DEVICE INSERTION WAS TECHNICALLY DIFFICULT DUE TO PATIENT ANATOMY AND RESISTANCE ENCOUNTERED IN THE AORTA; NO EXCESSIVE FORCE WAS APPLIED, AND A GUIDEWIRE WAS USED. FOLLOWING PLACEMENT, LOSS OF PALPABLE PULSES WAS NOTED IN THE LEFT (IMPELLA) EXTREMITY, AND DOPPLER-ONLY PULSES WERE DIFFICULT TO OBTAIN IN ALL EXTREMITIES. LIMB ISCHEMIA WAS DIAGNOSED BASED ON LOSS OF PULSES; BOTH LIMBS WERE REPORTED AS ISCHEMIC. THE ONSET OF ISCHEMIA WAS REPORTED TO HAVE BEGUN PRIOR TO INTRODUCER INSERTION. VASCULAR SURGERY MANAGED THE ISCHEMIA; WHETHER THE ISCHEMIA RESOLVED AND WHETHER REMOVAL OF THE IMPELLA IMPROVED PERFUSION ARE UNKNOWN. THE PATIENT¿S ACTS WERE REPORTEDLY BETWEEN 160 AND 180 SECONDS AROUND THE TIME OF PUMP STOP. THE IMPELLA CP REMAINED IN PLACE UNTIL EXPLANT ON (B)(6) 2026 AT 13:30. CARE WAS SUBSEQUENTLY WITHDRAWN, AND THE PATIENT EXPIRED ON (B)(6) 2026. NO DEVICE MALFUNCTION, DAMAGE, OR PUMP REPLACEMENT WAS REPORTED. NO DATA DOWNLOAD WAS REQUIRED, NO PRODUCT RETURN WAS REQUESTED, AND NO CONSOLE SERIAL NUMBER WAS AVAILABLE. CONCLUSION: THIS COMPLAINT INVOLVES A REPORTED PATIENT INJURY OF LIMB ISCHEMIA IN THE SETTING OF IMPELLA CP SUPPORT IN A PATIENT WITH SEVERE PERIPHERAL ARTERIAL DISEASE AND EXTENSIVE VASCULAR CALCIFICATIONS. THE ISCHEMIA WAS ATTRIBUTED TO THE IMPELLA BY THE REPORTER; HOWEVER, SIGNIFICANT PRE-EXISTING VESSEL DISEASE, ANATOMICAL CHALLENGES, AND ISCHEMIA REPORTEDLY BEGINNING PRIOR TO INTRODUCER INSERTION WERE IDENTIFIED AS CONTRIBUTING FACTORS. THE PATIENT OUTCOME WAS DEATH FOLLOWING WITHDRAWAL OF CARE, WHICH WAS NOT ATTRIBUTED TO A CONFIRMED DEVICE MALFUNCTION. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA CP BUT IS UNLIKELY RELATED AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SCAI STAGE B SHOCK ON MULTIPLE INOTROPES AND PRESSORS AND WAS VENTILATED FOR RESPIRATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411153 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027848991 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1