BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 19575208 · Received June 20, 2024

    Report

    Report Number
    1220648-2024-12570
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    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

    THE INVESTIGATION FOR 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 DUE TO ANTICOAGULATION MANAGEMENT SINCE THE ACTIVATED CLOTTING TIME WAS 258 IN THE INTENSIVE CARE UNIT WHICH IS ABOVE THE RANGE LIMIT. AS NOTED IN THE IMPELLA INSTRUCTIONS FOR USE: IMPELLA CP WITH SMART ASSIST 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).¿ B.7 REVISED AS INFORMATION WAS INADVERTENTLY OMITTED FROM THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12570. D.4 REVISED MODEL NUMBER FROM THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12570 IN ACCORDANCE WITH UPDATED PROCEDURES. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12570 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FDA. G.1 REVISED MANUFACTURING SITE NAME AND ADDRESS SECTION AS PREVIOUSLY ENTERED INCORRECTLY ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12570. G.2 FOREIGN WAS SELECTED INCORRECTLY ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12570. H.3 REVISED SELECTION FOR WAS THE DEVICE EVALUATED BY THE MANUFACTURER SINCE THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12570 AS THE DEVICE WAS DISCARDED. H.6 CODE 4114 WAS REPORTED INCORRECTLY ON THE PREVIOUSLY SUBMITTED MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12570. A NEW CODE HAS BEEN ADDED TO TYPE OF INVESTIGATION CODES. H.10 ADDITIONAL MANUFACTURER NARRATIVE INSTRUCTIONS FOR USE WERE REVISED FROM THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-12570 IN ACCORDANCE WITH UPDATED PROCEDURES. ADDITIONAL MANUFACTURER NARRATIVE ON THE PREVIOUSLY SUBMITTED REPORT 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 · 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).¿

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 69-YEAR-OLD FEMALE UNDERGOING CARDIAC SURGERY WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. US COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA CP SUPPORT AND THEY HAD ACCESS SITE BLEEDING. MANUAL COMPRESSION WAS HELD, ANGLE MATCHING WAS APPROPRIATE, AND DRESSING CHANGED, THEN FEMOSTOP PLACED. FEMOSTOP ADJUSTED, THEN REMOVED AND MANUAL COMPRESSION HELD WITH DECREASED BLEEDING, BUT STILL CONTINUED TO OOZE. THE IMPELLA WAS THEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654945 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025493101 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention