BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 22303598 · Received June 21, 2025

    Report

    Report Number
    1220648-2025-29645
    Event Type
    Injury
    Date Received
    June 21, 2025
    Date of Event
    June 3, 2025
    Report Date
    October 30, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502013276
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF PRODUCT DAMAGE (CATHETER KINK), HIGH PURGE PRESSURE, AND STROKE HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. PRODUCT DAMAGE (CATHETER KINK): PRODUCT WAS NOT RETURNED FOR INVESTIGATION, HOWEVER, AN IMAGE WAS. IN THE IMAGE IT APPEARS THERE IS A KINK IN THE CATHETHER JUST OUTSIDE THE TOUHY-BORST VALVE WITHIN THE STERILE SLEEVE. HOWEVER, WITHOUT RETURNED PRODUCT TO CONFIRM THE CATH-ANCHOR IS FUNCTIONING PROPERLY, THE ROOT CAUSE OF THE CATHETER KINK COULD NOT BE DETERMINED DEFINITIVELY. DATA LOGS ARE NOT RELEVANT TO THE REPORTED ISSUE. SINCE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE CATHETER KINK COULD NOT BE DETERMINED. HIGH PURGE PRESSURE: DATA LOGS WERE NOT AVAILABLE FOR INVESTIGATION AND PRODUCT WASN'T RETURNED FOR INVESTIGATION. SINCE NEITHER DATA LOGS NOR PRODUCT WERE AVAILABLE FOR REVIEW, THE ROOT CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DETERMINED. STROKE/CVA: THE ROOT CAUSE OF THE STROKE/CVA WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. INSTRUCTIONS FOR USE: IMPELLA 5.5 WITH SMARTASSIST SECTION: USING THE AUTOMATED IMPELLA CONTROLLER WITH THE IMPELLA CATHETER ¿UNRESOLVED PURGE PRESSURE HIGH ALARM IF NOT RESOLVED BY THE RECOMMENDATIONS PROVIDED, HIGH PURGE PRESSURE¿WHICH TRIGGERS THE ¿PURGE PRESSURE HIGH¿ ALARM MESSAGE¿COULD BE AN INDICATION OF A KINK IN THE IMPELLA CATHETER. IN THIS CASE, THE MOTOR IS NO LONGER BEING PURGED AND MAY EVENTUALLY STOP. CLINICIANS SHOULD MONITOR MOTOR CURRENT AND CONSIDER REPLACING THE IMPELLA CATHETER WHENEVER A RISE IN MOTOR CURRENT IS SEEN.¿ IMPELLA 5.5 WITH SMART ASSIST FOR USE DURING CARDIOGENIC SHOCK 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).¿ SECTION: WARNINGS, CAUTIONS & PRECAUTIONS: ¿TO REDUCE THE POSSIBILITY OF FIBERS BEING DRAWN INTO THE IMPELLA, CUSTOMERS SHOULD AVOID EXPOSING THE INLET AND CANNULA SECTION OF THE IMPELLA HEART PUMPS TO ANY SURFACES OR FLUID BATHS WHERE THE DEVICE CAN COME INTO CONTACT WITH LOOSE OR FLOATING FIBERS.¿ IT WAS DISCOVERED THAT HIGH PURGE PRESSURE AND STROKE WERE REPORTED IN A DUPLICATE MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-30206. THE FOLLOWING CORRECTIONS WERE MADE TO MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-29645 TO INCLUDE HIGH PURGE PRESSURE AND STROKE AND THE INVESTIGATION RESULTS. B1 ADVERSE EVENT WAS INADVERTENTLY OMITTED B5 UPDATED WITH CORRECTIVE STATEMENT AND PATIENT NARRATIVE. H1 TYPE OF REPORT WAS ERRONEOUSLY SELECTED. H6 HEALTH EFFECT - CLINICAL CODE 4582 AND HEALTH EFFECT - IMPACT CODE 2199 WERE ERRONEOUSLY ENTERED. H6 COMPONENT CODE 925 WAS INADVERTENTLY OMITTED. H10 INSTRUCTIONS FOR USE WERE INADVERTENTLY OMITTED.

    Additional Manufacturer Narrative · 0

    THE PUMP AND PURGE CASSETTE WERE RETURNED FOR INVESTIGATION. NO DATA LOGS WERE RETURNED FOR ANALYSIS. PRODUCT DAMAGE (CATHETER KINK): CLINICAL DETAILS REPORT THAT THE CATHETER WAS KINKED ON (B)(6) 2025. THE TEAM WAS UNABLE TO MOVE THE CATHETER THROUGH THE TOUHY-BORST VALVE DUE TO THE KINK. FOR THIS REASON, THEY COULD NOT REPOSITION THE PUMP. THAT BEING SAID, POSITION WAS CHECKED VIA IMAGING AND CONFIRMED TO BE GOOD. NO EXCESSIVE FORCE WAS REPORTEDLY USED. NO FURTHER DETAILS WERE PROVIDED. AN IMAGE WAS RETURNED IN ADDITION TO THE PRODUCT. IN THE IMAGE IT APPEARS THERE IS A KINK IN THE CATHETER JUST OUTSIDE THE TOUHY-BORST VALVE WITHIN THE STERILE SLEEVE, WHICH WAS CONFIRMED DURING PRODUCT EVALUATION. DATA LOGS ARE NOT RELEVANT TO THE REPORTED ISSUE. THE ROOT CAUSE OF THE CATHETER KINK WAS NOT DETERMINED DUE TO LACK OF SUFFICIENT CLINICAL DETAILS. HIGH PURGE PRESSURE: THE ROOT CAUSE OF THE HIGH PURGE PRESSURE WAS MOST LIKELY BIOMATERIAL IN THE PURGE GAP BASED ON THE PRODUCT EVALUATION. SINCE NO DATA LOGS WERE RETURNED FOR ANALYSIS, IT COULD NOT BE CONFIRMED WHETHER IT WAS BIOMATERIAL BUILDUP OR INGESTION. THE PUMP WAS FURTHER INVESTIGATED FOR THROMBUS IN CASE OF INGESTION. STROKE/CVA: THE ROOT CAUSE OF THE STROKE/CVA WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THROMBUS: THE ROOT CAUSE OF THE THROMBUS WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. D9 DEVICE RETURNED TO MANUFACTURER DATE ADDED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 COULD NOT BE REPOSITIONED BECAUSE OF A CABLE PROBLEM INSIDE THE REPOSITIONING UNIT OUTSIDE THE BODY. THERE WAS A POOR PROCESSING IN THE CABLE SO THAT IT DID NOT FIT INTO THE TOUHY BURST. THE PUMP WAS SECURED BUT THERE WAS NO CHANCE TO REPOSITION THE PUMP. THE PATIENT WAS STILL ON SUPPORT. THE PUMP'S POSITION WAS VERIFIED AND WAS OK. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    HIGH PURGE PRESSURE AND CEREBRAL HEMORRHAGE WAS REPORTED UNDER MANUFACTURER DEVICE REPORT 1220648-2025-30206. 25-45798 IS A DUPLICATE OF THIS COMPLAINT. INVESTIGATING RESULTS WILL BE SUBMITTED UNDER THIS MANUFACTURER DEVICE REPORT 1220648-2025-29645. THE COMPLAINANT REPORTED THAT NINETEEN DAYS INTO IMPELLA 5.5 SUPPORT, THE PURGE FLOW DROPPED WHILE THE PURGE PRESSURE INCREASED TO 1000 MMHG. LYSIS THERAPY WAS DISCUSSED BUT ULTIMATELY DECLINED DUE TO THE PATIENT'S EXISTING CEREBRAL HEMORRHAGE. INFORMATION PERTAINING TO THE BLEED AND ITS ORIGIN WAS NOT PROVIDED. THE STAFF WAS ADVISED TO REPLACE THE PUMP AND DECISIONS REGARDING FURTHER TREATMENT WERE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453026 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026665339 00813502013276

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other