BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24600335 · Received March 14, 2026

    Report

    Report Number
    1220648-2026-05265
    Event Type
    Injury
    Date Received
    March 14, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 15, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: D1 BRAND NAME UPDATED. ADDITIONAL INFORMATION WAS PROVIDED THAT STATES THAT THE THERE WAS NO TREATMENT TO THE GI BLEED PRIOR TO EXPLANT. ADDITIONALLY, THE DEVICE IS EXPECTED TO BE RETURNED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 SERIAL NUMBER. UPON REVIEW, IT WAS IDENTIFIED THAT THE (E1) INITIAL REPORTER FACILITY NAME, INITIAL REPORTER ADDRESS LINE 1, INITIAL REPORTER CITY, INITIAL REPORTER STATE, ZIP CODE AND ZIP CODE EXTENSION WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE INFORMATION HAS NOW BEEN PROVIDED. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE POSITIONING ISSUE WAS LIKELY USE RELATED AS EVIDENCED BY POSITIONING ISSUE OCCURRING RIGHT AFTER PATIENT MOVEMENT TO ICU BED CONFIRMED BY IMAGING SOWING PUMP OUTSIDE VENTRICLE.

    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.

    Description of Event or Problem · 0

    A 48 YEAR OLD FEMALE WITH AN INDICATION FOR USE OF IMPELLA CP FOR ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK PRESENTED IN A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE E. THE IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY USING PERCUTANEOUS ACCESS ON (B)(6) 2026 AT 05:22. AFTER INSERTION, THE PEEL AWAY SHEATH WAS REMOVED, FORWARD TENSION SUTURES WERE APPLIED, AND THE TOUHY AND T LOCK WERE SECURED. DURING TRANSFER TO THE ICU BED, AN ¿IMPELLA IN AORTA¿ ALARM TRIGGERED. THE ACCESS SITE WAS ASSESSED, AND THE CATHETER WAS NOTED TO BE APPROXIMATELY 10 CM SHALLOWER THAN ITS DOCUMENTED FINAL IMAGING POSITION. STAFF RECHECKED THE TOUHY AND T LOCK, BOTH OF WHICH REMAINED SECURED. REPEAT IMAGING DEMONSTRATED THAT THE IMPELLA, INCLUDING THE PIGTAIL, HAD MIGRATED OUT OF THE LEFT VENTRICLE AND INTO THE AORTA. GIVEN THE PATIENT¿S SEVERE NEUROLOGICAL DEFICITS AND SIGNIFICANT GASTROINTESTINAL BLEED, THE CLINICAL TEAM ELECTED TO REMOVE THE IMPELLA WITHOUT REPLACEMENT. THE DEVICE WAS EXPLANTED AT 07:00 ON (B)(6) 2026. IMAGING HAD BEEN USED TO CONFIRM PUMP POSITION AT THE TIME OF INSERTION, AND THE PUMP WAS INITIALLY IN GOOD POSITION. NO PRODUCT RETURN IS EXPECTED; WITH NO RETURN OF DEVICE, NO EVALUATION CAN BE PERFORMED. THE PATIENT SURVIVED TO EXPLANT AND WAS REPORTED AS SURVIVING THE COMPLAINT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5783 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027839098 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1