BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 6533786 · Received May 1, 2017

    Report

    Report Number
    1220648-2017-00031
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    April 2, 2017
    Report Date
    April 2, 2017
    Manufacturer
    ABIOMED EUROPE GMBH
    Product Code
    OJE
    UDI-DI
    00813502010022
    PMA / PMN Number
    H140001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPELLA RP WAS NOT RETURNED FOR EVALUATION, AS IT WAS DISCARDED SUBSEQUENT TO THE EVENT. THEREFORE, NO DEVICE ANALYSIS COULD BE PERFORMED. THE CONSOLE LOGS WERE RETURNED FOR ANALYSIS. THE LOGS HOWEVER DO NOT CONTRIBUTE ANY INFORMATION TO THE ROOT CAUSE OF THE EVENT. THERE IS NO ANOMALY IN THE DATA LOGS, WITH THE LOGS SHOWING NORMAL PUMP PERFORMANCE. THE PULMONARY BLEED WAS MOST LIKELY CAUSED BY REPEATED ADVANCEMENT AND MANIPULATION OF GUIDEWIRES INTO THE PULMONARY ARTERY DURING THE DIFFICULT POSITIONING OF THE RP. NO CORRECTIVE ACTION IS RECOMMENDED AS THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. FAILURES OF THIS TYPE WILL BE MONITORED AND TRENDED. THE MANUFACTURER WILL CONTINUE TO INVESTIGATE ALL REASONABLE OBTAINABLE SOURCES OF INFORMATION AND WILL PROVIDE RESULTS AND CONCLUSIONS IN A SUPPLEMENTAL MEDWATCH REPORT IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A MALE PATIENT OF UNKNOWN AGE WAS ADMITTED TO THE MEDICAL FACILITY IN RIGHT VENTRICULAR FAILURE POST PLACEMENT OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IN (B)(6) OF 2017. THE PATIENT WAS TAKEN TO THE CARDIAC CATH LAB FOR PLACEMENT OF THE IMPELLA RP FOR RIGHT SIDED HEART SUPPORT. THE PATIENT WAS ACCESSED AND A SWAN-GANZ CATHETER WAS PLACED WITH SOME DIFFICULTY. THE SWAN WAS EXCHANGED OUT OVER AN .018 V18 WIRE AND THE IMPELLA RP WAS ADVANCED. OF NOTE IN THE IFU FOR THE IMPELLA RP THE WIRE RECOMMENDATION IS AS SUCH: "A 0.025 INCH, 260 CM PLATINUM PLUS OR SIMILAR STIFF PLACEMENT GUIDEWIRE IS USED FOR THE PLACEMENT OF THE IMPELLA RP® CATHETER" THERE IS NO RECOMMENDATION TO USE A V18 WIRE FOR PLACEMENT. THERE WAS PLACEMENT DIFFICULTY AS THE WIRE WAS PULLED BACK, AND SO THE RP WAS REMOVED AND THE SWAN RE-ADVANCED. THE PHYSICIAN CHOSE THEN TO USE A "BUDDY WIRE TECHNIQUE" AND PLACE THE .018 V18 WIRE AND PLATINUM PLUS WIRE INTO THE LEFT PULMONARY ARTERY VIA THE SWAN. THE RP WAS SUCCESSFULLY THEN POSITIONED OVER THE .025 WIRE AND DELIVERED APPROPRIATE FLOWS. THE LVAD DEVICE ALSO HAD IMPROVED FLOWS WITH THE RP SUPPORT RUNNING CONCURRENT. THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING AND PLACEMENT OF THE RP WAS CONFIRMED BY X-RAY AND ECHO. DURING THE NEXT 2-4 HOURS THE PATIENT'S CONDITION DETERIORATED. THERE WAS QUESTION OF BLEEDING INTO THE PATIENT'S LEFT LUNG. ALTHOUGH THERE WAS NO PROOF, THE PHYSICIAN BELIEVED THAT THE BLEEDING WAS DUE TO A PULMONARY ARTERY PERFORATION FROM GUIDEWIRE INSERTION. ON THE FOLLOWING DAY, THE PATIENT HAD THE IMPELLA RP EXPLANTED, AND EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) PLACED. ECMO AND THE LVAD CONTINUE TO SUPPORT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316444 IMPELLA RIGHT VENTRICULAR BYPASS ASSIST DEVICE OJE ABIOMED EUROPE GMBH IMPELLA RP 1230922 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L ECMO| HEART MATE| INTERNAL JUGULAR SWAN| PLATINUM PLUS WIRE, .025| V18 WIRE