BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RP FLEX W SMART ASSIST SET, US

    MDR report key: 24262920 · Received February 4, 2026

    Report

    Report Number
    1220648-2026-02263
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 4, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    PYX
    UDI-DI
    00813502012811
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE HAS NOT BEEN POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    D2A AND D2B: CORRECTED THE DEVICE COMMON NAME AND PRO-CODE. D4: CORRECTED THE DEVICE INFORMATION PER A REVIEW OF THE COMPLAINT RECORD. H4: CORRECTED THE MANUFACTURER DATE. H6: ADDED CODE F01 AND G04105. OMITTED CODE G04074.

    Additional Manufacturer Narrative · 0

    ASAE / HEMATOMA: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN 83-YEAR-OLD MALE WITH AN INDICATION FOR ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK, PRESENTING CONSISTENT WITH SCAI STAGE D PRE SUPPORT, UNDERWENT PLACEMENT OF AN IMPELLA RP FLEX DEVICE (PUMP 1, PC (B)(4), GU CASE (B)(4)). DURING THE PROCEDURE ON (B)(6) 2026 AT 3:35 PM, AFTER REMOVAL OF THE 23 FRENCH PEEL AWAY SHEATH AND ADVANCEMENT OF THE REPOSITION SHEATH, THE PATIENT DEVELOPED A HEMATOMA AT THE RIGHT INTERNAL JUGULAR VENOUS ACCESS SITE. A MATTRESS SUTURE HAD BEEN APPLIED PRIOR TO VESSEL DILATION AND WAS TIGHTENED, BUT A HEMATOMA STILL FORMED. THE CARE TEAM APPLIED MANUAL PRESSURE, RESULTING IN RESOLUTION OF THE HEMATOMA. THE PATIENT REMAINED STABLE, AND THE DEVICE REMAINS ON SUPPORT WITH EXPLANT DATE PENDING. THE INTRODUCER IS EXPECTED TO BE RETURNED FOR EVALUATION. THE REPORTED FAILURE MODE IS HEMATOMA. BASED ON AVAILABLE INFORMATION, THE EVENT APPEARS RELATED TO ACCESS SITE VASCULAR COMPLICATIONS, AND THERE IS NO EVIDENCE AT THIS TIME TO INDICATE A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216367 RP FLEX W SMART ASSIST SET, US TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. - 1220648 KIT, 23FR INTRODUCER, 11CM, STERILE 2026772150 00813502012811

    Patients

    Seq Age Sex Outcome Treatment
    1