BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 21843954 · Received April 15, 2025

    Report

    Report Number
    1220648-2025-27506
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    March 20, 2025
    Report Date
    October 17, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF INFECTION/SEPSIS AND VF/VT/AF/AT HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED. B1 PRODUCT PROBLEM WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27506. B2. OTHER SERIOUS EVENT SELECTION WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27506. B3. DATE OF EVENT WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27506. B5. REVISED WITH INFORMATION THAT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27506. E4. SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27506 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. H6. HEALTH EFFECT - CLINICAL CODE 2095 AND HEALTH EFFECT - IMPACT CODE 4614 WERE INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27506. H6. MEDICAL DEVICE PROBLEM CODE 1158 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27506.

    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. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA 5.5 WITH SMARTASSIST FOR USE DURING CARDIOGENIC SHOCK. SECTION: TABLE 3.2 IMPELLA CATHETER COMPONENTS ¿THE INFUSION FILTER PREVENTS BACTERIAL CONTAMINATION AND AIR FROM ENTERING THE PURGE LUMEN.¿ SECTION: WARNINGS & CAUTIONS: WARNINGS. ¿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.¿

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES, PER FDA RECOMMENDATION. THE INVESTIGATION HAS BEEN COMPLETED. THE PUMP WAS NOT RETURNED FOR INVESTIGATION. ACCORDING TO THE GIVEN CLINICAL INFORMATION, SEVERAL SELF-RESOLVING IMPELLA POSITION IN AORTA ALARMS WERE REPORTED DURING THE CASE, PARTICULARLY WITH THE PATIENT COUGHING AND MOVING. THE DATA LOG RECORDED SEVERAL IMPELLA POSITION UNKNOWN ALARMS, INDICATING THE IMPELLA POSITION IN THE AORTA. THERE WERE NO SUCTION ALARMS, AND NO TRENDS IN MOTOR CURRENT OR PLACEMENT SIGNALS WERE OBSERVED DURING THE CASE. SIGNAL-TO-NOISE RATIO (SNR) WAS REPORTED FLUCTUATING WITHIN THE SPECIFICATION RANGE THROUGHOUT THE CASE RUN, REGARDLESS OF THE PRESENCE OF FALSE POSITION IN AORTA ALARMS. NO OTHER 5S PARAMETERS WERE AFFECTED DURING THE CASE. THE CAUSE OF THE OPTICAL SIGNAL ISSUE WAS MOST LIKELY PATIENT CONDITION RELATED, BASED ON CLINICAL DETAILS AND DATA LOG REVIEW. AN INFECTION/SEPSIS CAN OCCUR DURING OR AFTER IMPELLA SUPPORT. WHEN DIAGNOSING THE CAUSE OF AN INFECTION IN A PATIENT, THE FOLLOWING CLINICAL EVIDENCE WOULD NEED TO BE CONSIDERED HOLISTICALLY: PATIENT SYMPTOMS AND MEDICAL HISTORY OBTAINED BY THE TREATING CLINICIAN PHYSICAL EXAMINATION FINDINGS RESULTS OF SPECIAL INVESTIGATIONS : LABORATORY TEST RESULTS & IMAGING STUDIES MICROBIOLOGICAL CULTURE AND SENSITIVITY RESULTS RESPONSE TO PREVIOUS TREATMENTS AND THERAPIES ANY RELEVANT EPIDEMIOLOGICAL INFORMATION OR EXPOSURE HISTORY CONCOMITANT DEVICES IN USE PREEXISTING PATIENT CONDITION SUCH AS UNDERLYING INFECTION, REMOTE SEPTIC SOURCES SUCH AS INDWELLING LINES/CATHETERS OR OTHER BIOPROSTHETIC MATERIAL IN SITU. CARE OF ACCESS SITE BECAUSE THIS EVIDENCE HAS NOT BEEN PROVIDED, THE ROOT CAUSE OF THE INFECTION CANNOT BE DETERMINED. CARDIAC ARRYTHMIA CAN BE REPORTED DURING IMPELLA SUPPORT. TO MAKE A DETERMINATION AS TO THE CAUSE OF THE CARDIAC ARRYTHMIA, THE FOLLOWING CLINICAL INFORMATION MUST BE CONSIDERED: PATIENT'S MEDICAL HISTORY, INCLUDING ANY PRE-EXISTING CARDIAC CONDITIONS, PREVIOUS EPISODES OF ARRHYTHMIAS, OR STRUCTURAL HEART DISEASE. TIMING OF THE ARRYTHMIA EVENT IN RELATION TO IMPELLA SUPPORT (DURING OR POST-IMPLANT) ELECTROCARDIOGRAM (EKG) RECORDINGS OF THE ARRHYTHMIA EPISODES. EVALUATION OF ANY UNDERLYING ELECTRICAL DISTURBANCES, SUCH AS QT PROLONGATION OR ELECTROLYTE IMBALANCES. ASSESSMENT OF HEMODYNAMIC INSTABILITY DURING THE ARRHYTHMIA, INCLUDING BLOOD PRESSURE AND CARDIAC OUTPUT MEASUREMENTS. PRESENCE OF OTHER POTENTIALLY CONTRIBUTORY FACTORS, SUCH AS MEDICATION CHANGES, ISCHEMIA, OR ELECTROLYTE ABNORMALITIES. RESPONSE TO ANY ANTIARRHYTHMIC TREATMENTS OR INTERVENTIONS DURING THE EVENT ANY DOCUMENTED DEVICE-RELATED ISSUES OR COMPLICATIONS DURING IMPELLA SUPPORT EVALUATION OF POTENTIAL TRIGGERS OR PRECIPITATING FACTORS, SUCH AS CATHETER MANIPULATION, REPERFUSION INJURY, OR INCREASED MYOCARDIAL OXYGEN DEMAND. REVIEW OF ANY CONCOMITANT MEDICATIONS THAT MAY INFLUENCE CARDIAC ELECTROPHYSIOLOGY WITH A RETURNED IMPELLA, THE DEVICE CAN BE INSPECTED FOR ANY BURRS OR ROUGH EDGES THAT MAY CONTACT THE HEART WALL. TO DETERMINE THE TRUE ROOT CAUSE OF THE VT/VF, THE CLINICAL INFORMATION MENTIONED ABOVE WOULD NEED TO BE ASSESSED IN CONJUNCTION WITH EVIDENCE FROM THE RETURNED DEVICE. AS THE NECESSARY INFORMATION WAS NOT PROVIDED, THE ROOT CAUSE OF THE VT/VF WAS NOT DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUSPECT PRODUCT AND HISTORICAL COMPLAINT DATA WAS CONDUCTED. THIS REVIEW REVEALED THAT THE PRODUCT MET ALL MANUFACTURING RELEASE CRITERIA, AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED AT THE TIME THE PRODUCT WAS MANUFACTURED AND RELEASED TO THE CUSTOMER. ALL PERTINENT INFORMATION AVAILABLE TO ABIOMED HAS BEEN SUBMITTED AT THIS TIME. H6 UPDATED TO INCLUDE PLACEMENT SIGNAL CODING. D10 CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES UPDATED.

    Description of Event or Problem · 0

    THE PATIENT WAS HAVING SOME COMPENSATORY PAUSES AND SHORT VENTRICULAR TACHYCARDIA (VT) RUNS FOLLOWED BY IMPELLA IN AORTA ALARMS WHICH LASTED 5-10 SECONDS. IT WAS DISCUSSED HOW PAUSES CAN BRIEFLY AFFECT PRELOAD AND DECREASE MOTOR CURRENT DIFFERENTIAL TO LESS THAN 50MA WHICH CAN TRIGGER FALSE IMPELLA IN AORTA ALARMS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED CONTINUOUS INTERMITTENT 'IMPELLA IN AORTA' ALARMS WERE ENCOUNTERED FOR WHICH A DISCUSSION WAS GIVEN ON HOW THEY COULD BE TRIGGERED. THE FALSE IMPELLA IN AORTA ALARMS CONTINUED TO APPEAR WHENEVER THE PATIENT COUGHED OR MOVED BUT WOULD SELF-RESOLVE. ADDITIONALLY, THE PATIENT SHADED FOR POSITIVE BLOOD CULTURES ON ANTIBIOTICS AND LINE HOLIDAY. HOWEVER, A FEW DAYS LATER THE PATIENT BECAME UNSHADED POST RESOLUTION OF INFECTION. THE PATIENT REMAINS ON SUPPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED OPTICAL SENSOR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134326 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026619134

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other| R AUTOMATED IMPELLA CONTROLLER.