BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 21047059 · Received December 31, 2024

    Report

    Report Number
    1220648-2024-25221
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    December 13, 2024
    Report Date
    May 9, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD ADDITIONAL INFORMATION REGARDING THROMBOCYTOPENIA, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. B5 REVISED WITH ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SITE. H6 REVISED TO REFLECT THE ADDITIONAL INFORMATION G2 REPORT SOURCE; STUDY WAS MISSING FROM MANUFACTURER DEVICE REPORT 1220648-2024-25221.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: IMPELLA CP WITH SMARTASSIST SYSTEM. SECTION: GENERAL PATIENT CARE CONSIDERATIONS: ¿ASSESS ACCESS SITE FOR BLEEDING AND HEMATOMA.¿ SECTION: ENTERING CARDIAC OUTPUT: USE OF THE REPOSITIONING SHEATH AND PEEL-AWAY INTRODUCER. ¿REMOVE THE PEEL-AWAY INTRODUCER COMPLETELY FROM THE ARTERY OVER THE CATHETER SHAFT TO PREVENT TRAUMA AND SIGNIFICANT BLEEDING AND APPLY MANUAL PRESSURE ABOVE THE PUNCTURE SITE.¿ SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES): ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY¿ (INCLUDING VENTRICULAR PERFORATION).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF ACCESS SITE BLEEDING HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE ACCESS SITE BLEEDING WAS MOST LIKELY USE ISSUE SINCE HEMOSTASIS WAS ACHIEVED BY ADDING ADDITIONAL SUTURE. E4 SHOULD HAVE BEEN LEFT BLANK ON MANUFACTURER DEVICE REPORT 1220648-2024-25221.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA LOQI (ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR IMPELLA REGISTRY) OF ACUTE THROMBOCYTOPENIA. RELATIONSHIP TO PUMP IS LISTED AS "POSSIBLY". LOQI STATES: PATIENT HAD IMPELLA/EXPLANT/HEART TRANSPLANT ON (B)(6) 2024. OVERNIGHT PATIENT HAD BLEEDING AND REQUIRED MASSIVE TRANSFUSION (5 PRBCS, 4 FFPS, 2 PLATELETS, AND 10 CRYO). ON (B)(6) 2024, PATIENT HAD CHEST EXPLORATION AND WASHOUT, WHERE MINOR BLEEDING WAS CAUTERIZED. PLATELET TREND FROM (B)(6) 2024: 89-40-132-159-174-184.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT AS A BRIDGE TO HEART TRANSPLANT, AND EIGHT DAYS INTO SUPPORT, IMPELLA ACCESS SITE BLEEDING OCCURRED. THERE WERE MULTIPLE DRESSING CHANGES, AND EXTRA SUTURE WAS APPLIED. ADDITIONALLY, AN ARM SLING WAS USED TO MINIMIZE THE PATIENT MOVEMENT. NEXT DAY THERE WAS NO ACTIVE OOZING FROM ACCESS SITE ONLY WITH PATIENT MOVEMENT. FOLLOWING THIS DAY, IMPELLA ACCESS SITE WAS STILL SLIGHTLY SATURATED AND MANAGED WITH A DRESSING CHANGE. THE DONOR WAS AVAILABLE, THE PATIENT WAS TRANSPORTED AND QUICKLY LISTED FOR HEART TRANSPLANT AFTER ARRIVAL. THE PATIENT TOLERATED THE IMPELLA 5.5 SUPPORT AND WAS BRIDGED TO HEART TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116278 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025539709 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention