BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 19607525 · Received June 25, 2024

    Report

    Report Number
    1220648-2024-12676
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    November 6, 2023
    Report Date
    August 1, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR ACCESS SITE BLEEDING AND VENTRICULAR TACHYCARDIA (VT) HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF ACCESS SITE BLEEDING WAS DETERMINED TO BE PATIENT CONDITION BECAUSE OF THE PATIENT'S HISTORY OF THROMBOCYTOPENIA WHERE THE PATIENT HAS ABNORMALLY LOW LEVELS OF PLATELETS IN THEIR BLOOD. AS THE NECESSARY INFORMATION WAS NOT PROVIDED, THE ROOT CAUSE OF THE VT WAS NOT DETERMINED. B.7 INFORMATION WAS ADDED AS IT WAS INADVERTENTLY OMITTED FROM THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12676. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12676 AND SHOULD NOT HAVE BEEN. H.6 CODE 4755 WAS ENTERED INCORRECTLY ON THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12676. A NEW COMPONENT CODE HAS BEEN ADDED. CODE 4114 WAS REPORTED INCORRECTLY ON THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12676. A NEW CODE HAS BEEN ADDED TO TYPE OF INVESTIGATION CODES. H.10 ADDITIONAL MANUFACTURER NARRATIVE ON THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12676 STATED THAT THE DEVICE WAS NOT RETURNED BUT THE DEVICE WAS DISCARDED. TYPE OF INVESTIGATION CODES HAS BEEN UPDATED TO REFLECT DISCARDED. ADDITIONAL MANUFACTURER NARRATIVE INSTRUCTIONS FOR USE (IFUS) WERE REPORTED ON THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12676 INCORRECTLY. NO IFUS ARE NEEDED TO BE REPORTED FOR THIS REPORT IN ACCORDANCE WITH UPDATED PROCEDURES.

    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: 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).¿ SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES) ¿ARRHYTHMIA, ATRIAL FIBRILLATION, BLEEDING, CARDIAC TAMPONADE, CARDIOGENIC SHOCK, DEATH, DEVICE MALFUNCTION, HEMOLYSIS, HEPATIC FAILURE, INSERTION SITE INFECTION, PERFORATION, PHLEGMASIA CERULEA DOLENS (A SEVERE FORM OF DEEP VENOUS THROMBOSIS), PULMONARY VALVE INSUFFICIENCY, RESPIRATORY DYSFUNCTION, SEPSIS, THROMBOCYTOPENIA, THROMBOTIC VASCULAR (NON-CENTRAL NERVOUS SYSTEM COMPLICATION, TRICUSPID VALVE INJURY, CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION), VENOUS THROMBOSIS, VENTRICULAR FIBRILLATION AND/OR TACHYCARDIA.¿

    Description of Event or Problem · 0

    WE RECEIVED A NOTIFICATION VIA ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR IMPELLA REGISTRY REGARDING A PATIENT THAT ENDURED MEDIASTINAL BLEEDING FROM IMPELLA SURGERY WITH A "POSSIBLE" RELATIONSHIP TO THE IMPELLA DEVICE USED: ¿AFTER IMPELLA IMPLANTED, DUE TO PATIENT'S HISTORY OF THROMBOCYTOPENIA (SETTING ONGOING COAGULOPATHY), THERE WAS ONGOING BLEEDING AT THE MEDIASTINAL SITE. STERNAL WIRES APPLIED TO STOP BLEEDING ALONG WITH WOUND VAC WAS PLACED. H/H BASELINE IS UNKNOWN. H/H IS 11.1 AND 31.8. H/H PEAK IS 12.2/34.3. ACUTE CARE SURGERY WAS FOLLOWING. PATIENT CONTINUED TO HAVE WOUND VAC POST DISCHARGE¿. IT WAS REPORTED THAT THE PATIENT/EVENT HAS NOT RECOVERED/NOT RESOLVED. WE RECEIVED A NOTIFICATION VIA ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR IMPELLA REGISTRY REGARDING A PATIENT THAT ENDURED WORSENING VENTRICULAR TACHYCARDIA WITH A "POSSIBLE" RELATIONSHIP TO THE IMPELLA DEVICE USED: ¿ON EVENING (B)(6) 2023, PATIENT HAD INCREASED VENTRICULAR ECTOPY ON TELEMETRY. PATIENT HAD EPICARDIAL PACER ON BUT UNDERSENSING AND NOT CAPTURING. WHILE EXAMINING EXTERNAL PACER WIRES, PATIENT WENT INTO MONOMORPHIC VT (VENTRICULAR TACHYCARDIA) (220S). PATIENT RECEIVED 6 SHOCKS 200J UNIPOLAR. BRIEF RETURN NSR BETWEEN SHOCKS FOLLOWED BY ANOTHER VT (APPROX 15 MINS). AMIODARONE AND LIDOCAINE BOLUSES GIVEN PRIOR TO START OF CONTINUOUS DRIPS. BEDSIDE ECHO CONFIRMED IMPELLA WAS POSITIONED CORRECTLY. SETTINGS FOR EXTERNAL PACER CHANGED. PATIENT DIDN'T HAVE CT (COMPUTED TOMOGRAPHY) AFTER. PATIENT CONTINUED TO BE MONITORED FOR VT POST DISCHARGE IN INPATIENT SKILLED FACILITY¿. IT WAS REPORTED THAT THE PATIENT/EVENT HAS NOT RECOVERED/NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697896 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2024399767 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention