BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP

    MDR report key: 19259444 · Received May 7, 2024

    Report

    Report Number
    1220648-2024-10844
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 23, 2024
    Report Date
    July 2, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4 CATALOG NUMBER, SERIAL NUMBER, LOT NUMBER, EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI) # ARE UNKNOWN. D.6A AND D.6B IMPLANT AND EXPLANT DATES ARE UNKNOWN. H.4 DEVICE MANUFACTURE DATE IS UNKNOWN. THE IMPELLA DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. IMPELLA RP WITH SMART ASSIST SYSTEM WITH AUTOMATED IMPELLA CONTROLLER SECTION: WARNINGS & CAUTIONS: WARNINGS: SECTION: PRE-SUPPORT EVALUATION. SECTION: AXILLARY INSERTION OF THE IMPELLA 5.5 CATHETER. SECTION: DIRECT AORTIC INSERTION. SECTION: USE OF IMPELLA WITH TRANSCATHETER AORTIC VALVES. " IN PATIENTS WITH TRANSCATHETER AORTIC VALVES POSITION THE IMPELLA SYSTEM CAREFULLY TO AVOID INTERACTION WITH THE TRANSCATHETER AORTIC VALVE PROSTHESIS. UNINTENTIONAL INTERACTION OF THE IMPELLA MOTOR HOUSING WITH THE TAVR DEVICE MAY RESULT IN DESTRUCTION OF THE IMPELLER BLADES. THIS CAN LEAD TO SYSTEMIC EMBOLIZATION, SERIOUS INJURY, OR DEATH. IN THIS SITUATION, AVOID REPOSITIONING WHILE THE DEVICE IS RUNNING; TURN THE DEVICE TO P0 DURING REPOSITIONING OR ANY MOVEMENT THAT COULD BRING THE OUTLET WINDOWS INTO PROXIMITY TO THE VALVE STENT STRUCTURES. IF THERE IS LOW FLOW OBSERVED IN A PATIENT IMPLANTED WITH A TRANSCATHETER AORTIC VALVE PROSTHESIS, CONSIDER DAMAGE OF THE IMPELLER AND REPLACE THE IMPELLA AS SOON AS POSSIBLE.¿

    Additional Manufacturer Narrative · 0

    A.1, A.4 AND A.5 ARE UNKNOWN. THE INVESTIGATION INTO THE REPORTED ISSUE HAS BEEN COMPLETED SINCE THE ORIGINAL REPORT WAS SUBMITTED. THE COMPLAINT IS FROM A LITERATURE REPORT WITH MISSING INFORMATION. NO CASE NUMBERS, DEVICE SERIAL NUMBERS, OR CLINICAL INFORMATION WAS PROVIDED. NO PRODUCT OR DATA LOGS WERE AVAILABLE FOR REVIEW. THE ROOT CAUSE OF HEART VALVE DAMAGE WAS NOT DETERMINED DUE TO LACK OF CLINICAL INFORMATION AND NO RETURNED PRODUCT. LITERATURE CITATION: BERTOLIN, S., MAJ, G., SECCO, G. G., PULLARA, A., GHERLI, R., CARDINALE, A., D¿ETTORE, N., CAVOZZA, C., AUDO, A., & PAPPALARDO, F. (2023). TIMING, POSITIONING AND ANCILLARY THERAPIES: THE TRIAD FOR SUCCESSFUL IMPELLA RP. JOURNAL OF CARDIOVASCULAR MEDICINE. HTTPS://DOI.ORG/10.2459/JCM.0000000000001563 A.3 REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844 WAS SUBMITTED. B.1 PRODUCT PROBLEM WAS SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844 AND SHOULD NOT HAVE BEEN. B.2 DEATH WAS SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844 AND SHOULD NOT HAVE BEEN. B.5 REVISED TO REFLECT PATIENT NUMBER TWO ONLY SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844 WAS SUBMITTED. E.1 FACILITY NAME WAS REVISED AS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844. G.1 REVISED REPORTING CONTACT FAX NUMBER IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844 WAS SUBMITTED. H.6 CODES 1802,1158 AND 925 WERE REPORTED INCORRECTLY ON THE PREVIOUSLY SUBMITTED REPORT. NEW CODES HAVE BEEN ADDED TO MEDICAL DEVICE PROBLEM CODE AND HEALTH EFFECT - IMPACT CODE. H.10 A.1, A.4 AND A.5 ARE UNKNOWN STATEMENT AND LITERATURE CITATION WERE INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844. ATTACHMENTS: PUBLICATION WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844.

    Description of Event or Problem · 0

    THE COMPLAINANT FROM THE ITALIAN PUBLICATION ENTITLED "TIMING, POSITIONING AND ANCILLARY THERAPIES: THE TRIAD FOR SUCCESSFUL IMPELLA RP" OUTLINED THREE PATIENT CASES. CASE TWO HAD "TRICUSPID REGURGITATION EMERGED DUE TO DEVICE INTERFERENCE WITH SEPTAL TRICUSPID LEAFLET" AND CASE THREE HAD PUMP MALPOSITIONING AND KINKING OBSERVED. CASE TWO SURVIVED AND CASE THREE EXPIRED.

    Description of Event or Problem · 0

    THIS REPORT WILL REPRESENT PATIENT NUMBER TWO. PATIENT NUMBER TWO HAD "TRICUSPID REGURGITATION EMERGED DUE TO DEVICE INTERFERENCE WITH SEPTAL TRICUSPID LEAFLET". THE PATIENT SURVIVED. MANUFACTURER REPORT NUMBER 1220648-2024-12890 REPRESENTS PATIENT NUMBER THREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401865 IMPELLA RP TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. IMPELLA RP EU

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Life Threatening| D| S