BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIT, 14FR INTRODUCER, 13CM&25CM, STERILE

    MDR report key: 24115436 · Received January 20, 2026

    Report

    Report Number
    1220648-2026-01126
    Event Type
    Death
    Date Received
    January 20, 2026
    Date of Event
    January 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED REPORTING THE PATIENT OUTCOME OF DEATH, THE FOLLOWING FIELDS WERE UPDATE BASED ON THE INFORMATION RECEIVED FROM THE CLINICAL SITE. B1, B2, B5, H1, H6. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. D9 UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE PREPPING THE INTRODUCER SHEATH IT WAS NOTED THAT THERE WAS NO HOLE. THE SHEATH WAS EXCHANGED FOR SUCCESSFUL IMPELLA IMPLANTATION. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    A 72-YEAR-OLD MALE PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK, WITH THE PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE E. DURING DEVICE PREPARATION, THE SCRUB TECHNICIAN OBSERVED THAT THE SHORT PEEL AWAY INTRODUCER SHEATH VALVE (INTRODUCER SHORT SHEATH, (B)(4), SN (B)(6)) DID NOT CONTAIN AN OPENING IN THE VALVE. THE TEAM ELECTED NOT TO USE THE SHORT SHEATH AND INSTEAD PROCEEDED WITH THE LONG SHEATH TO COMPLETE THE PROCEDURE. THE PATIENT WAS SUPPORTED WITH AN IMPELLA CP PUMP (PUMP 1 OF 1, MODEL 644906, (B)(4); GU CASE (B)(4)), IMPLANTED VIA THE RIGHT FEMORAL ARTERY PERCUTANEOUSLY ON (B)(6) 2026 AT 09:30 AND EXPLANTED THE SAME DAY AT 11:40. THE SHORT SHEATH IS AVAILABLE FOR PRODUCT RETURN AND INVESTIGATION. DESPITE SUPPORT, THE PATIENT EXPIRED ON (B)(6) 2026 AT 11:40 WHILE ON SUPPORT. THE REPORTED FAILURE MODES INCLUDE A DEFECTIVE SHEATH AND SUBSEQUENT PATIENT DEATH. BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE OBSERVED SHEATH DEFECT DIRECTLY CONTRIBUTED TO THE PATIENT¿S CLINICAL DECLINE, WHICH WAS CONSISTENT WITH THE SEVERITY OF THE UNDERLYING CARDIOGENIC SHOCK. THE DEATH IS CONSERVATIVELY BEING REPORTED ON THE IMPELLA CP BUT IS UNLIKELY A CONTRIBUTING FACTOR TO CAUSE OF DEATH AND IS MORE LIKELY DUE TO THE PATIENT UNDERLYING CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182456 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9883250

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death