BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24702180 · Received March 26, 2026

    Report

    Report Number
    1220648-2026-06007
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 20, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    004260113630303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6B AND D9 UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WERE PROVIDED IN D3, AND E1. UPON REVIEW, IT WAS IDENTIFIED THAT THESE WERE INADVERTENTLY OMITTED FROM THE INITIAL REPORT. UPDATED H3 TO ¿YES¿ AS THE DEVICE WAS RECEIVED AND EVALUATED. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE PRESENCE OF KINK AND DEFORMED COIL ON THE RETURNED GUIDEWIRE WAS RELATED TO THE REMOVAL ISSUE; HOWEVER, THE CAUSE COULD NOT BE DETERMINED WITHOUT SUFFICIENT CLINICAL DETAILS. GUIDEWIRE KINKING AND COIL DEFORMATION DAMAGE WERE CONFIRMED ON THE RETURNED PRODUCT; HOWEVER, THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITHOUT SUFFICIENT CLINICAL DETAILS.

    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

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 VIA LEFT SURGICAL DIRECT AORTA FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT X 3 WITH AORTIC VALVE REPLACEMENT, ATRIAL APPENDAGE MAZE PROCEDURE. PRE PROCEDURE 10 X 30 VASCULAR GRAFT WAS PLACED ON AORTA. POST PROCEDURE THE DOCTORS PLACED IMPELLA 5.5 THROUGH 23 FRENCH AXILLARY SHEATH. THE DOCTOR DID NOT WANT TO IMPLANT THE IMPELLA WIRELESSLY. UNDER TRANSESOPHAGEAL ECHOCARDIOGRAM GUIDANCE, THE PIGTAIL WAS 65 CENTIMETERS WITH JWIRE CROSSED THE NEW AV. ABIOMED 0.18 WAS PLACED IN THE LEFT VENTRICLE. THE IMPELLA BACKLOADED AND PLACED ACROSS THE AV. WHEN THE MEDICAL DOCTOR ATTEMPTED TO PULL OUT THE WIRE HE STATED ¿IT WAS STUCK¿. HE MET RESISTANCE AND THE DECISION WAS MADE TO PULL THE PUMP BACK AND OUT. UPON EXPLANT, A KINK WAS NOTED IN THE WIRE. AFTER REMOVAL, MULTIPLE WIRES AND GUIDES WERE USED TO TRY AND RECROSS AND EVENTUALLY THE DOCTOR SUCCESSFULLY CROSSED THE AV AND SAME PUMP CROSSED. THE DOCTOR STATED THE WIRE REMOVAL AGAIN WAS TIGHT BUT THE WIRE WAS REMOVED. HE STATED¿ I HAVE PLACED MANY PUMPS AND FEELS IT WAS THE PRODUCT NOT ANATOMY. THE PUMP POST PLACEMENT WAS FLOWING WELL. THE DEVICE WAS DISCARDED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218434 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 9464328 004260113630303

    Patients

    Seq Age Sex Outcome Treatment
    1