BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23217970 · Received October 4, 2025

    Report

    Report Number
    1220648-2025-47187
    Event Type
    Injury
    Date Received
    October 4, 2025
    Date of Event
    September 2, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WAS TRANSFERRED FROM (B)(6) TRANSFER FACILITY: (B)(6) STREET ADDRESS: (B)(6) PHONE: (B)(6) FAX: (B)(6) WEBSITE: (B)(6) CITY: (B)(6) STATE/PROVINCE: (B)(6) ZIP/POSTAL CODE: (B)(6) COUNTRY: (B)(6)

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED FOR INVESTIGATION. MAJOR BLEED: ACCESS SITE BLEEDING AROUND THE SHEATH. THE ROOT CAUSE OF THE BLEEDING WAS UNABLE TO BE DETERMINED AS INSUFFICIENT CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR ANALYSIS. TACHYCARDIA: IN ORDER TO MAKE A ROOT CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN (B)(4) WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE TACHYCARDIA WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1917633. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE WITH SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS. AS PER QN (B)(4), THIS QN HAS BEEN OPENED TO INVESTIGATE THE LEGIBILITY, COMPLETENESS, AND SCANABILITY OF 2000193 BATCHES. LOT 1920527 WAS ORIGINALLY IN THE SCOPE OF THIS QN; HOWEVER, IT IS NOT MATERIAL 2000193. LOT 1920527 IS MATERIAL 2000154; THEREFORE, IT HAS BEEN ADDED THE TO CORRESPONDING QN FOR THIS CONTAINMENT UNDER THE CORRECT MATERIAL NUMBER (QN (B)(4)) AND REMOVED FROM THIS QN. ALL INVESTIGATION AND REWORK ACTIVITIES REMAIN APPLICABLE, AS ALL QNS ARE FOR THE SAME LABEL ISSUE AND REQUIRE THE SAME CORRECTION. THE MULTIPLE QNS WERE MADE ONLY TO SEPARATE THE AFFECTED LOTS BY MATERIAL NUMBER. ADDITIONAL QNS FOR THIS LABELING ISSUE INCLUDE (B)(4). RWK QTY CORRECTION: ORIGINAL INTENDED REWORK WAS FOR QTY 324 PUMPS; HOWEVER, ADDITIONAL, UNRELATED NCS WERE IDENTIFIED ON PUMPS (B)(6). MRB FURTHER REVIEWED THE FOLLOWING LOTS AND DETERMINED QTY 3 PUMPS DID NOT PASS THE LABEL REWORK RE-INSPECTION PER 0000-8400RT. NO FURTHER INVESTIGATION IS REQUIRED, AS THE PUMPS FAILED DUE TO HANDLING DURING THE RWK PROCESS. PUMP WITH SN: (B)(6) FROM LOT 1919492, PUMP WITH SN: (B)(6) FROM LOT 1921852, PUMP WITH SN: (B)(6) FROM LOT 1919480, THE ABOVE PUMPS HAVE BEEN LABELED AS SCRAP AND NOT FOR HUMAN USE. THE REMAINING 6 PUMPS IN THESE LOTS PASSED REINSPECTION, PER THE ATTACHED DATA SHEET AND WILL BE ACCEPTED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA 5.5 EXPERIENCED BLEEDING FROM THE ACCESS SITE. SYSTEMIC HEPARIN WAS WITHHELD. THE PATIENT ALSO EXPERIENCED VENTRICULAR TACHYCARDIA REQUIRING CARDIOVERSION AND ADMINISTRATION OF ALBUMIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440129 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026667310

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention