BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24518479 · Received March 5, 2026

    Report

    Report Number
    1220648-2026-04511
    Event Type
    Death
    Date Received
    March 5, 2026
    Date of Event
    March 1, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    CORRECTED INFORMATION WAS PROVIDED IN D1 (BRAND NAME). UPON REVIEW, IT WAS IDENTIFIED THAT THE SECTION D BRAND NAME HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN D3, G1 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN E3 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT USE RELATED AS THE ISSUE RESOLVED WITH APPROPRIATE ANGLE, MATCH AND FORWARD TENSION.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 71-YEAR-OLD MALE PRESENTING WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. THE PATIENT HAD A PAST MEDICAL HISTORY SIGNIFICANT FOR CORONARY ARTERY DISEASE AND DIABETES MELLITUS. CARDIOGENIC SHOCK WAS CLASSIFIED AS SCAI STAGE E. PRIOR TO DEVICE INSERTION, THE PATIENT¿S LACTATE LEVEL WAS REPORTED AS 6.4 AND THE LEFT VENTRICULAR EJECTION FRACTION WAS REPORTED AS 30 PERCENT. THE PATIENT REQUIRED INOTROPIC AGENTS, VASOPRESSORS, AND MECHANICAL VENTILATION FOR RESPIRATORY SUPPORT. DURING THE INTERVENTION THE PATIENT UNDERWENT CORONARY ANGIOPLASTY INCLUDING LEFT ANTERIOR DESCENDING AND LEFT CIRCUMFLEX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WITH STENT PLACEMENT, AS WELL AS LASER ANGIOPLASTY. DURING SUPPORT, A HEMATOMA WAS NOTED AT THE RIGHT FEMORAL ACCESS SITE. A FIRM STOP WAS PLACED AND THE ACCESS SITE WAS MANAGED USING APPROPRIATE ANGULATION AND FORWARD TENSION. COMPUTED TOMOGRAPHY OF THE PELVIS WAS COMPLETED AND DID NOT DEMONSTRATE RETROPERITONEAL BLEEDING. THE REPORTED EVENTS INCLUDED ACCESS SITE HEMATOMA, HEMOSTASIS MANAGEMENT, ADMINISTRATION OF TWO UNITS OF PACKED RED BLOOD CELLS, AND ACCESS SITE BLEEDING REQUIRING TRANSFUSION. DESPITE THESE INTERVENTIONS, THE PATIENT¿S CLINICAL STATUS REMAINED CRITICAL. THE PATIENT PRESENTED WITH SEVERE CARDIOGENIC SHOCK REQUIRING MULTIPLE VASOACTIVE MEDICATIONS AND VENTILATORY SUPPORT IN THE SETTING OF ACUTE MYOCARDIAL INFARCTION AND COMPLEX CORONARY INTERVENTION. ACCESS SITE BLEEDING AND HEMATOMA FORMATION ARE RECOGNIZED COMPLICATIONS ASSOCIATED WITH LARGE-BORE ARTERIAL ACCESS, PARTICULARLY IN CRITICALLY ILL PATIENTS REQUIRING ANTICOAGULATION AND COMPLEX PERCUTANEOUS CORONARY INTERVENTIONS. PATIENT CONTINUED TO DETERIORATE CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474394 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027831892 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| D