BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24845689 · Received April 10, 2026

    Report

    Report Number
    1220648-2026-06651
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    April 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    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

    THE PRODUCT WAS DISCARDED AFTER EXPLANT. 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 (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 INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: A 75-YEAR-OLD MALE PATIENT UNDERWENT PRE-OPERATIVE PLACEMENT OF AN IMPELLA 5.5 VIA SURGICALLY PLACED RIGHT AXILLARY/SUBCLAVIAN ARTERIAL ACCESS ON (B)(6) 2026 AT 09:58 FOR HEMODYNAMIC SUPPORT. THE PATIENT¿S PRE-SUPPORT CLINICAL STATUS WAS CONSISTENT WITH SCAI SHOCK STAGE D. POST-IMPLANT, THE PATIENT DEVELOPED ACUTE BLEEDING, WITH APPROXIMATELY 1300 ML OF BLOOD OUTPUT FROM A LEFT PLEURAL CHEST TUBE OVER A TWO-HOUR PERIOD. THE PATIENT WAS TAKEN EMERGENTLY BACK TO THE OPERATING ROOM FOR OPEN CHEST EXPLORATION. INTRAOPERATIVELY, IT WAS DISCOVERED THAT A TEMPORARY VENTRICULAR PACING (TVP) WIRE HAD PERFORATED THE LEFT INTERNAL MAMMARY ARTERY (LIMA), RESULTING IN THE BLEEDING. THE TVP WIRE WAS REPOSITIONED CORRECTLY, AND THE LIMA WAS SURGICALLY REPAIRED. THE CHEST WAS CLOSED, AND THE PATIENT WAS RETURNED TO THE UNIT. THE PATIENT RECEIVED MULTIPLE BLOOD PRODUCTS, AND BLEEDING REMAINED STABLE OVERNIGHT. THERE WERE NO ALLEGATIONS OF DEVICE MALFUNCTION, NO REQUEST FOR PRODUCT REPLACEMENT, NO PRODUCT AVAILABLE FOR RETURN, AND NO DEVICE DOWNLOAD WAS REQUIRED. REVIEW OF THE CLINICAL INFORMATION SUPPORTS THAT THE BLEEDING EVENT WAS ATTRIBUTABLE TO TVP WIRE-RELATED VASCULAR INJURY AND WAS NOT RELATED TO THE IMPELLA DEVICE OR ITS FUNCTION IN ANY WAY. THE IMPELLA 5.5 REMAINED IN USE UNTIL EXPLANT ON (B)(6) 2026 AT 13:17, AND THE PATIENT SURVIVED THROUGH EXPLANT WITH NO DEVICE-RELATED COMPLICATIONS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145181 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026631358 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1