BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CPSA C9+ SET, OUS

    MDR report key: 24575657 · Received March 11, 2026

    Report

    Report Number
    1220648-2026-05053
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    February 22, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013344
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 D3, G1 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (SERIAL, PRIMARY UDI NUMBER). UPON REVIEW, THE SECTION D UDI AND SERIAL NUMBER HAVE NOW BEEN UPDATED. 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 INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED AND LIMITED CLINICAL DETAILS WERE PROVIDED.

    Description of Event or Problem · 0

    CLINICIAN NARRATIVE AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 41-YEAR-OLD MALE PRESENTING WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. NO PAST MEDICAL HISTORY WAS PROVIDED. THE DEVICE WAS PLACED TO PROVIDE TEMPORARY MECHANICAL CIRCULATORY SUPPORT IN THE SETTING OF HEMODYNAMIC COMPROMISE. THE PURGE SOLUTION CONSISTED OF DEXTROSE 5 PERCENT IN WATER WITH 25 MILLIEQUIVALENTS OF SODIUM BICARBONATE. DURING SUPPORT, ELEVATED PURGE SYSTEM PRESSURES WERE REPORTED. THE CLINICAL TEAM CONTACTED SUPPORT TO CLARIFY HOW TO PROCEED IN THE SETTING OF A PURGE PRESSURE HIGH CONDITION. RECOMMENDATIONS PROVIDED INCLUDED CONSIDERATION OF PUMP EXCHANGE OR ADMINISTRATION OF TISSUE PLASMINOGEN ACTIVATOR TO ADDRESS POTENTIAL OBSTRUCTION WITHIN THE PURGE SYSTEM. UPON ADDITIONAL INFORMATION RECEIVED, THE PROVIDER REPORTED THAT TISSUE PLASMINOGEN ACTIVATOR WAS NOT ADMINISTERED AND THE IMPELLA CP PUMP WAS SUBSEQUENTLY REMOVED. PATIENTS PRESENTING WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK FREQUENTLY REQUIRE COMPLEX HEMODYNAMIC MANAGEMENT AND MECHANICAL CIRCULATORY SUPPORT. PURGE PRESSURE ELEVATIONS MAY OCCUR DUE TO CHANGES IN PURGE LINE RESISTANCE, THROMBUS FORMATION, OR OTHER CLINICAL FACTORS ASSOCIATED WITH CRITICAL ILLNESS AND ANTICOAGULATION MANAGEMENT. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122355 IMPELLA CPSA C9+ SET, OUS TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026794565 00813502013344

    Patients

    Seq Age Sex Outcome Treatment
    1